Chrysalis Intelligence · Sponsors · Medtronic Vascular

Medtronic Vascular

Danvers, MA, US · 4 510(k) clearances · 330 PMAs · 18 recalls (5 Class I)

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Total clearances
4
2022-04-13 → 2023-10-24
Last 12 months
0
Product codes
3
Most recent
2023-10-24
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DQY — — — 2 2023-08-22
DQX Wire, Guide, Catheter Class II Cardiovascular 1 2023-10-24
MAV — — — 1 2022-04-13
Class III

PMA approvals (330)

Total PMA records
330
Originals + supplements
Distinct product codes
9
First decision
2020-01-09
Most recent
2026-08-14
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-08-14 P160043-S095 Resolute Onyx Zotarolimus-Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2026-07-10 P110023-S068 EverFlex™ Self-expanding Peripheral Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2026-07-10 P060001-S058 Protege™ GPS™ Self-expanding Peripheral Stent System 30-Day Notice NIM — —
2026-06-05 P160043-S094 Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent System Stent S 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2026-05-29 P160043-S093 RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2026-05-21 P190008-S049 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2026-05-13 P160043-S092 Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent System Stent S 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2026-05-12 P100021-S132 Endurant™ II/IIs Stent Graft System Normal 180 Day Track No User Fee MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2026-05-01 P190008-S048 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2026-04-27 P200026-S018 Abre™ Venous Self-expanding Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2026-04-23 P190008-S047 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2026-04-23 P110023-S067 Everflex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2026-04-17 P140018-S049 VenaSeal™ Closure System 30-Day Notice PJQ — —
2026-04-08 P200026-S017 Abre™ Venous Self-expanding Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2026-03-25 P160043-S090 Onyx Frontier Zotarolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2026-03-23 P200026-S016 Abre™ Venous Self-expanding Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2026-03-23 P110023-S066 EverFlex™ Self-Expanding Peripheral Stent System; EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2026-03-23 P060001-S057 Protégé™ GPS™ Self-Expanding Peripheral Stent System; Protégé™ RX Carotid Stent System 30-Day Notice NIM — —
2026-03-11 P140018-S048 VenaSeal™ Closure System 30-Day Notice PJQ — —
2026-02-27 P100040-S074 Valiant™ Thoracic Stent Graft with the Captivia™ Delivery System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2026-02-27 P100021-S134 Endurant™, Endurant™ II/lls Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2026-02-20 P110023-S064 EverFlex™ Self-Expanding Peripheral Stent System; EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2026-02-20 P060001-S055 Protege™ RX Carotid Stent System; Protege™ GPS™ Self-Expanding Peripheral Stent System 30-Day Notice NIM — —
2026-02-13 P190008-S046 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2026-02-11 P110023-S065 EverFlex™ Self-Expanding Peripheral Stent System; EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2026-02-11 P060001-S056 Protege™ RX Carotid Stent System; Protege™ GPS™ Self-Expanding Peripheral Stent System 30-Day Notice NIM — —
2026-02-09 P110023-S063 EverFlex™ Self-Expanding Peripheral Stent System; EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2026-01-30 P190008-S038 IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter 135 Review Track For 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2026-01-27 P100021-S133 Endurant Stent Graft System; Endurant II/IIs Stent Graft System; Endurant II AUI Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2026-01-23 P060001-S054 Protégé RX Carotid Stent System 30-Day Notice NIM — —
2025-12-19 P160043-S089 Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW; Onyx Frontier Zotarolimus-Eluting Coronary Stent S 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2025-12-16 P060001-S053 Protégé™ GPS™ Self-expanding Peripheral Stent System 30-Day Notice NIM — —
2025-12-12 P200026-S015 Abre Venous Self-expanding Stent System Special (Immediate Track) QAN Stent, Iliac Vein Unknown
2025-11-07 P110023-S061 EverFlex self-expanding Peripheral Stent System (EverFlex) Real-Time Process NIP Stent, Superficial Femoral Artery Unknown
2025-11-07 P060001-S052 Protégé GPS self-expanding Peripheral Stent System Real-Time Process NIM — —
2025-10-23 P100021-S131 Endurant II/IIs Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-10-02 P110023-S062 EverFlex™ Self-expanding Peripheral Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2025-09-26 P140018-S047 VenaSeal Closure System 30-Day Notice PJQ — —
2025-09-23 P200026-S014 Abre Venous Self-expanding Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2025-09-23 P140018-S046 VenaSeal™ Closure System 30-Day Notice PJQ — —
2025-09-16 P190008-S045 IN.PACT AV Paclitaxel-coated PTA Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2025-09-15 P100021-S129 Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System Real-Time Process MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-08-13 P060001-S051 Protege™ RX Carotid Stent System 30-Day Notice NIM — —
2025-08-12 P190008-S044 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2025-08-05 P110023-S056 EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) Normal 180 Day Track NIP Stent, Superficial Femoral Artery Unknown
2025-07-25 P110023-S060 EverFlex™ Self-Expanding Peripheral Stent System; EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2025-07-25 P060001-S050 Protege™ RX Carotid Stent System; Protege™ GPS™ Self-Expanding Peripheral Stent System 30-Day Notice NIM — —
2025-07-17 P060001-S049 Protégé™ RX Carotid Stent System Special (Immediate Track) NIM — —
2025-07-15 P190008-S043 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2025-07-10 P190008-S041 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2025-07-09 P190008-S042 IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2025-07-09 P190008-S040 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2025-06-26 P160043-S088 Resolute Onyx 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2025-06-26 P110023-S059 EverFlex™ Self-expanding Peripheral Stent with Entrust™ Delivery System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2025-06-12 P100040-S073 Valiant Thoracic Stent Graft with the Captivia Delivery System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-06-12 P100021-S130 Endurant Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-05-29 P190008-S039 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2025-05-20 P140018-S044 VenaSeal Closure System Normal 180 Day Track PJQ — —
2025-05-20 P100040-S072 Valiant Thoracic Stent Graft with the Captivia Delivery System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-05-09 P110023-S058 EverFlex™ Self-Expanding Peripheral Stent System; EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2025-05-09 P060001-S047 PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS 30-Day Notice NIM — —
2025-05-08 P100040-S069 Valiant Thoracic Stent Graft with the Captiva Delivery System Normal 180 Day Track No User Fee MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-05-08 P100021-S125 Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System Normal 180 Day Track No User Fee MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-05-07 P060001-S048 Protégé RX Carotid Stent System; Protégé GPS Self-expanding Peripheral Stent System 30-Day Notice NIM — —
2025-04-11 P200026-S013 Abre™ Venous Self-expanding Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2025-04-07 P160043-S087 Resolute Onyx Zotarolimus Eluting Coronary Stent System RX and OTW; Onyx Frontier Zotarolimus Eluting Coronary Stent Sys 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2025-04-07 P100040-S071 Valiant Thoracic Stent Graft with the Captivia Delivery System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-04-07 P100021-S128 Endurant Stent Graft System; Endurant II Stent Graft System; Endurant II Stent AUI Graft System; Endurant IIs Stent Graf 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-03-26 P190008-S036 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter 135 Review Track For 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2025-03-07 P160043-S086 Parylene Tree Loading Machine 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2025-03-07 P110023-S057 EverFlex Self-Expanding Peripheral Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2025-03-07 P060001-S046 Protégé RX Carotid Stent System; Protégé GPS Self-Expanding Peripheral Stent System 30-Day Notice NIM — —
2025-02-28 P110023-S055 EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2025-01-24 P190008-S037 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter Special (Immediate Track) PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2025-01-21 P110023-S054 EverFlex™ Self-Expanding Peripheral Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2024-12-20 P100040-S070 Valiant Thoracic Stent Graft with the Captivia Delivery System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-12-20 P100021-S127 Endurant Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-12-13 P140018-S045 VenaSeal™ Closure System 30-Day Notice PJQ — —
2024-12-03 P190008-S033 IN.PACT AV DCB Real-Time Process PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2024-11-25 P110023-S053 EverFlex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-expanding Peripheral Stent with Entrust™ Delivery Syste 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2024-11-22 P190008-S035 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2024-11-22 P160043-S085 RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2024-11-20 P100021-S126 Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-11-18 P100040-S064 Valiant Thoratic Stent Graft with Captivia Delivery System Normal 180 Day Track No User Fee MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-10-21 P190008-S034 IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2024-10-18 P200026-S012 Abre™ Venous Self-expanding Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2024-10-10 P100040-S068 Valiant Thoracic Stent Graft with the Captivia Delivery System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-10-10 P100021-S124 Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-09-26 P160043-S084 RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2024-09-26 P100040-S066 Valiant Thoracic Stent Graft with the Captivia Delivery System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-09-26 P100021-S123 Endurant II Stent Graft System, Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System, Endurant IIs Stent Graft System, E 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-09-17 P110023-S052 EverFlex Self-Expanding Peripheral Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2024-09-10 P200026-S011 Abre™ Venous Self-expanding Stent Systems Self-expanding Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2024-09-10 P060001-S045 Protégé™ RX Carotid Stent System 30-Day Notice NIM — —
2024-09-09 P110023-S051 EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2024-09-05 P100040-S067 Valiant Thoracic Stent Graft with the Captivia Delivery System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-08-21 P060001-S044 Protégé™ GPS™ Self-Expanding Peripheral Stent System 30-Day Notice NIM — —
2024-08-15 P110023-S050 EverFlex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent with Entrust™ 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2024-07-26 P030045-S010 Visi-Pro™ Balloon-expandable Peripheral Stent System 30-Day Notice NIO Stent, Iliac Unknown
2024-07-10 P200026-S010 Abre™ Venous Self-expanding Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2024-07-10 P110023-S049 EverFlex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2024-07-10 P060001-S043 Protégé™ GPS™ Self-Expanding Peripheral Stent System, Protégé™ RX Carotid Stent System 30-Day Notice NIM — —
2024-07-01 P110023-S048 EverFlex Self-Expanding Peripheral Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2024-07-01 P110023-S047 EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2024-07-01 P060001-S042 Protege GPS Self-Expanding Peripheral Stent System 30-Day Notice NIM — —
2024-06-27 P190008-S030 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2024-06-21 P160043-S075 Resolute Onyx™ Zotarolimus Eluting Coronary Stent System Onyx Frontier™ Zotarolimus Eluting Coronary Stent System Normal 180 Day Track No User Fee NIQ Coronary Drug-Eluting Stent Unknown
2024-05-31 P200026-S009 Abre Venous Self-expanding Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2024-05-31 P060001-S041 Protégé™ GPS™ Self-Expanding Peripheral Stent System, and Protégé™ RX Carotid Stent System 30-Day Notice NIM — —
2024-05-30 P140018-S041 VENASEAL CLOSURE SYSTEM Real-Time Process PJQ — —
2024-05-08 P190008-S029 IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2024-05-08 P160043-S081 Resolute Onyx Rapid Exchange Zotarolimus­ Eluting Coronary Stent System, Resolute Onyx Frontier Rapid Exchange Zotarolim 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2024-05-08 P140018-S042 VenaSeal Closure System 30-Day Notice PJQ — —
2024-05-08 P100040-S063 Valiant Thoracic Stent Graft System (FreeFlo Tapers Line Extention) with Captivia Delivery System, Valiant Thoracic Sten 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-05-08 P100021-S121 Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System, Endurant II AUI Stent Graf 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-05-03 P110023-S046 EverFlex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2024-05-02 P110023-S045 EverFlex™ Self-Expanding Peripheral Stent System, 2 EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Sys 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2024-04-23 P190008-S028 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Normal 180 Day Track No User Fee PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2024-04-11 P160043-S079 Resolute Onyx Zotarolimus-Eluting Coronary Stent System-RX and OTW, Onyx Frontier Zotarolimus-Eluting Coronary Stent Sys 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2024-04-10 P160043-S080 Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW, Onyx Frontier Zotarolimus-Eluting Coronary Stent S 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2024-04-10 P100040-S062 Valiant Thoracic Stent Graft with the Captivia Delivery System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-04-10 P100021-S120 Medtronic CoreValve™ Evolut PRO System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-04-05 P200026-S008 Abre™ Venous Self-expanding Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2024-04-05 P110023-S044 EverFlex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2024-04-05 P060001-S040 Protégé™ RX Carotid Stent System, tégé™ GPS™ Self-Expanding Peripheral Stent System 30-Day Notice NIM — —
2024-04-05 P030045-S009 Visi-Pro™ Balloon-Expandable Peripheral Stent System, lntraStent™ DoubleStrut™ Stent 30-Day Notice NIO Stent, Iliac Unknown
2024-03-08 P160043-S078 Resolute Onyx Rapid Exchange Zotarolimus- Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus- Elutin 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2024-02-13 P200026-S007 Abre™ Venous Self-expanding Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2024-02-13 P110023-S043 EverFlex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2024-02-12 P160043-S077 Resolute Onyx RX Zotarolimus-Eluting Coronary Stent System, Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent System, 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2024-01-31 P160043-S076 Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System 30-Day Notice — — —
2024-01-31 P100040-S061 Valiant Thoracic Stent Graft with Captivia Delivery System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2024-01-31 P100021-S119 Endurant II Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-12-29 P100040-S060 Valiant Thoracic Stent Graft with the Captivia Delivery System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-11-21 P110023-S041 EverFlex™ Self-Expanding Peripheral Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2023-11-21 P060001-S038 Protégé™ GPS™ Self-Expanding Peripheral Stent System 30-Day Notice NIM — —
2023-11-01 P160043-S074 Resolute Onyx Zotarolimus-Eluting Coronary Stent System– RX and OTW 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2023-10-26 P030045-S008 Visi-Pro™ Balloon-expandable Peripheral Stent System 30-Day Notice NIO Stent, Iliac Unknown
2023-10-12 P190008-S027 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, CoreValve EnVeo R Delivery Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2023-10-12 P160043-S073 Resolute Onyx Over The Wire Zotarolimus-Eluting Coronary Stent System, Resolute Onyx Frontier Rapid Exchange Zotarolimus 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2023-10-12 P140018-S040 Venaseal Closure System 30-Day Notice PJQ — —
2023-10-10 P100040-S059 Valiant Thoracic Stent Graft with the Captivia Delivery System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-10-10 P100021-S118 Endurant Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-09-28 P160043-S071 Resolute Onyx RX Zotarolimus-Eluting Coronary Stent Systems, Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2023-09-18 P200026-S006 Abre Venous Self-expanding Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2023-09-18 P110023-S039 EverFlex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2023-09-18 P060001-S036 Protégé™ RX Carotid Stent System, Protégé™ GPS™ Self-Expanding Peripheral Stent System 30-Day Notice NIM — —
2023-09-15 P140018-S039 VenaSeal Closure System 30-Day Notice PJQ — —
2023-09-14 P190008-S025 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Normal 180 Day Track No User Fee PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2023-09-13 P100021-S117 Endurant, Endurant II and Endurant 11s Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-09-12 P110023-S040 EverFlex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2023-09-12 P060001-S037 Protégé™ RX Carotid Stent System, Protégé™ GPS™ Self-Expanding Peripheral Stent System 30-Day Notice NIM — —
2023-09-06 P140018-S038 VenaSeal Closure System 30-Day Notice PJQ — —
2023-09-05 P110023-S038 EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2023-08-30 P190008-S026 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2023-08-23 P100021-S116 Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-08-08 P160043-S066 Onyx Frontier Zotarolimus-Eluting Coronary Stent Systems 135 Review Track For 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2023-07-25 P140018-S037 VenaSeal Closure System Real-Time Process PJQ — —
2023-06-15 P160043-S070 Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems/ Onyx Frontier Zotarolimus-Eluting Coronary Stent Systems 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2023-06-06 P100040-S057 Valiant Thoracic Stent Graft with Captivia Delivery System, Endurant Stent Graft System, Endurant II Stent Graft System, 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-06-06 P100021-S114 Valiant Thoracic Stent Graft with Captivia Delivery System, Endurant Stent Graft System, Endurant II Stent Graft System, 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-06-02 P160043-S069 Resolute Onyx Zotarolimus-Eluting Coronary Stent System – RX and OTW, Onyx Frontier Zotarolimus-Eluting Coronary Stent S 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2023-06-02 P110023-S037 EverFlex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2023-06-02 P100040-S058 Valiant Thoracic Stent Graft with the Captivia Delivery System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-06-02 P100021-S115 Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graf 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-05-22 P190008-S024 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2023-05-04 P190008-S023 IN.PACT AV DCB 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2023-05-01 P160043-S068 Resolute Onyx (RX), Resolute Onyx (OTW), Resolute Onyx (RX) (2.0mm), Resolute Onyx (OTW) (2.0mm), Onyx Frontier RX Zotar 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2023-04-18 P160043-S067 Resolute Onyx RX Zotarolimus-Eluting Coronary Stent System, Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent System, 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2023-04-03 P140018-S033 VenaSeal™ Closure System 135 Review Track For 30-Day Notice PJQ — —
2023-03-23 P160043-S065 Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems, Onyx Frontier Zotarolimus-Eluting Coronary Stent Systems 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2023-03-17 P100040-S056 Valiant Thoracic Stent Graft with Captivia Delivery System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-03-17 P100021-S113 Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-03-02 P100021-S112 Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2023-03-02 P030045-S007 Visi-Pro Balloon-expandable Peripheral Stent System 30-Day Notice NIO Stent, Iliac Unknown
2022-12-15 P110023-S036 EverFlex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2022-12-15 P060001-S035 Protégé GPS Self-Expanding Peripheral Stent System, Protégé RX Carotid Stent System 30-Day Notice NIM — —
2022-12-01 P190008-S022 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2022-12-01 P160043-S064 Resolute Onyx Rapid Exchange Zotarolimus- Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus- Elutin 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2022-12-01 P140018-S036 VenaSeal Closure System 30-Day Notice PJQ — —
2022-12-01 P100040-S055 Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Thoracic Stent Graft (FreeFlo Tapers Line Extens 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-12-01 P100021-S111 Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graf 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-11-30 P100021-S109 Endurant Stent Graft System, Endurant II Stent Graft System, Eudurant IIs Stent Graft System, Endurant II Aorto-Uni-Ilia 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-11-28 P160043-S063 Resolute Onyx Rapid Exchange Zotarolimus-Eluting Coronary Stent System, Resoulute Onyx Over The Wire Zotarolimus-Eluting 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2022-11-28 P100040-S054 Valiant Thoracic Stent Graft (FreeFlo Tapers Line Extension) with the Captivia Delivery System and Valiant Thoracic Sten 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-11-28 P100021-S110 Endurant Stent Graft System, Endurant II Stent Graft System and Endurant II AUI Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-11-08 P140018-S035 VenaSeal™ Closure System 30-Day Notice PJQ — —
2022-11-01 P190008-S021 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2022-11-01 P160043-S062 Resolute Onyx Rapid Exchange Zotarolimus-Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus-Eluting 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2022-11-01 P100040-S053 Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Thoracic Stent Graft (FreeFlo Tapers Line Extens 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-11-01 P100021-S108 Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Talent Endoluminal Occl 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-10-27 P100040-S052 Valiant Thoracic Stent Graft with Captivia delivery System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-10-17 P100021-S106 Endurant Stent Graft System, Endurant II Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-10-13 P100021-S107 Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-10-11 P190008-S020 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2022-09-29 P160043-S060 Resolute Onyx Zotarolimus-Eluting Coronary Stent System Normal 180 Day Track No User Fee NIQ Coronary Drug-Eluting Stent Unknown
2022-09-29 P110013-S117 Resolute Integrity Normal 180 Day Track No User Fee NIQ Coronary Drug-Eluting Stent Unknown
2022-09-15 P160043-S058 Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System Panel Track NIQ Coronary Drug-Eluting Stent Unknown
2022-09-13 P140018-S034 VenaSeal ™ Closure System 30-Day Notice PJQ — —
2022-08-16 P100021-S105 Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-07-27 P140018-S032 VenaSeal Closure System Real-Time Process PJQ — —
2022-07-22 P200026-S005 Abre Venous Self-expanding Stent System Normal 180 Day Track No User Fee QAN Stent, Iliac Vein Unknown
2022-07-15 P160043-S045 Resolute Onyx Coronary Stent Systems 135 Review Track For 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2022-07-15 P110013-S109 Resolute Integrity Coronary Stent System 135 Review Track For 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2022-07-15 P100021-S089 Talent Occluder With Occluder Delivery System 135 Review Track For 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-07-08 P190008-S019 IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2022-06-15 P160043-S061 Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2022-06-07 P110023-S034 EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System Special (Immediate Track) NIP Stent, Superficial Femoral Artery Unknown
2022-06-03 P110023-S035 EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent System with Entrust Delivery S 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2022-06-03 P060001-S034 Protégé GPS Self Expanding Peripheral Stent System 30-Day Notice NIM — —
2022-05-23 P060001-S033 Protege RX Carotid Stent System Real-Time Process NIM — —
2022-05-13 P100021-S104 Endurant Stent Graft System, Endurant II Stent Graft System, Eudurant IIs Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-05-12 P160043-S055 Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System Normal 180 Day Track NIQ Coronary Drug-Eluting Stent Unknown
2022-04-20 P160043-S059 Resolute Onyx Zotarolimus-Eluting Coronary Stent System – RX and OTW 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2022-04-19 P110013-S116 Resolute Integrity Zotarolimus-Eluting Coronary Stent System – RX and OTW 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2022-04-19 P100040-S051 Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Navion Thoracic Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-04-19 P100021-S103 Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graf 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-04-07 P100021-S102 Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System Special (Immediate Track) MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-03-04 P190008-S018 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter Normal 180 Day Track No User Fee PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2022-02-24 P100021-S101 Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIS Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-02-17 P140018-S031 VenaSeal Closure System 30-Day Notice PJQ — —
2022-02-11 P200026-S004 Abre Venous Self-expanding Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2022-02-07 P100021-S100 Endurant II Stent Graft System, Endurant II Aort-Uni-Illac (AUI) Stent Graft System, Endurant IIs Stent Graft System, En 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-01-27 P190008-S015 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter 135 Review Track For 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2022-01-27 P160043-S048 Resolute Onyx Coronary Stent System 135 Review Track For 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2022-01-27 P140018-S026 Venaseal Closure System 135 Review Track For 30-Day Notice PJQ — —
2022-01-27 P110013-S112 Resolute Integrity Coronary Stent System 135 Review Track For 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2022-01-27 P100021-S093 Talent Occluder With Occluder Delivery System 135 Review Track For 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2022-01-13 P160043-S057 Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent Systems Special (Immediate Track) NIQ Coronary Drug-Eluting Stent Unknown
2022-01-11 P110023-S033 EverFlex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2022-01-03 P100021-S099 Endurant Stent Graft System, Endurant II Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-12-20 P100021-S098 Endurant Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-12-17 P190008-S007 IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter 135 Review Track For 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2021-12-17 P100021-S097 Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-12-14 P160043-S049 Resolute Onyx Zotarolimus-Eluting Coronary Stent System RX and OTW 135 Review Track For 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-12-14 P110013-S113 Resolute Integrity RX and OTW Zotarolimus-Eluting Coronary Stent System 135 Review Track For 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-12-10 P100040-S050 Valiant Captivia Stent Graft ith the Captivia Delivery System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-12-09 P190008-S017 IN.PACT® AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2021-12-09 P140018-S030 VenaSeal Closure System 30-Day Notice PJQ — —
2021-11-24 P160043-S056 Resolute Onyx RX Zotarolimus-Eluting Coronary Stent System, Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-11-19 P100021-S096 Endurant Stent Graft System; Endurant II Stent Graft System; Endurant IIS Stent Graft System Special (Immediate Track) MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-11-16 P110013-S115 Resolute Integrity RX Zotarolimus-Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-11-10 P100040-S049 Valiant Thoracic Stent Graft with the Captivia Delivery System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-11-05 P200026-S003 Abre Venous self-expanding stent system Special (Immediate Track) QAN Stent, Iliac Vein Unknown
2021-10-06 P140018-S028 VenaSeal Closure System 30-Day Notice PJQ — —
2021-09-10 P100021-S095 Endurant II Stent Graft System, Endurant IIs Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-08-31 P160043-S054 Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Resolute Onyx Zotarolimus-Eluting Coronary Stent System (2.0mm) 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-08-31 P110013-S114 Resolute Integrity Zotarolimus-Eluting Coronary Stent System, Resolute Integrity Zotarolimus-Eluting Coronary Stent Syst 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-08-13 P160043-S051 Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-08-09 P160043-S052 Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-08-05 P100040-S048 Valiant Thoracic Stent Graft with the Captivia Delivery System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-08-05 P100021-S094 Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System, Endurant II AUI Stent Graf 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-07-27 P160043-S050 Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-07-21 P190008-S016 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2021-07-09 P200026-S002 Abre Venous Self-expanding Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2021-06-15 P140018-S024 VenaSeal Closure System Real-Time Process PJQ — —
2021-05-28 P100021-S092 Endurant Stent Graft Family Normal 180 Day Track No User Fee MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-05-21 P190008-S014 IN.PACT AV DCB Special (Immediate Track) PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2021-05-21 P160043-S047 Resolute Onyx Zotarolimus-Eluting Coronary Stent System Special (Immediate Track) NIQ Coronary Drug-Eluting Stent Unknown
2021-05-21 P140018-S025 Venaseal Closure System Special (Immediate Track) PJQ — —
2021-05-21 P110013-S111 Resolute Integrity RX Zotarolimus-Eluting Coronary Stent System Special (Immediate Track) NIQ Coronary Drug-Eluting Stent Unknown
2021-05-21 P100040-S047 Valiant Navion Thoracic Stent Graft System, Valiant Thoracic Stent Graft with the Captivia Delivery System Special (Immediate Track) MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-05-21 P100021-S091 Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graf Special (Immediate Track) MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-05-11 P160043-S046 Resolute Onyx Zotarolimus-Eluting Coronary Stent System (hereafter called Resolute Onyx) 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-05-11 P110013-S110 Resolute Integrity Zotarolimus Eluting Coronary Stent Systems (hereafter called Resolute Integrity) 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-05-07 P200026-S001 Abre Venous Self-expanding Stent System 30-Day Notice QAN Stent, Iliac Vein Unknown
2021-05-07 P110023-S032 EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2021-05-07 P060001-S032 Protégé RX Self-expanding Stent System, Protégé GPS Self-Expanding Peripheral Stent System 30-Day Notice NIM — —
2021-05-07 P030045-S006 lntraStent DoubleStrut Stent, Visi-Pro Balloon-Expandable Peripheral Stent System 30-Day Notice NIO Stent, Iliac Unknown
2021-04-15 P100040-S046 Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Navion Thoracic Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-04-15 P100021-S090 Endurant, Endurant II and Endurant IIs Stent Graft System, Talent Occluder with Occluder Delivery System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-03-22 P140018-S022 VenaSeal Closure System 30-Day Notice PJQ — —
2021-03-12 P190008-S013 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2021-03-12 P160043-S044 Resolute Onyx Zotarolimus-Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-03-12 P110013-S108 Resolute Integrity zotarolimus-Eluting Coronary Stent Systems 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-03-12 P100040-S045 Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Navion Thoracic Stent Graft System and Valiant T 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-03-12 P100021-S088 Endurant Stent Grafyt System, Endurant II Stent Graft System, Ednurant II AUI Stent Graft System, Endurant IIs Stent Gra 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-03-02 P190008-S011 IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2021-03-02 P140018-S023 VenaSeal Closure System 30-Day Notice PJQ — —
2021-03-02 P100040-S044 Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Thoracic Stent Graft (FreeFlo Tapers Line Extens 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-03-02 P100021-S087 Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graf 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-02-23 P160043-S043 Resolute Onyx Zotarolimus-Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-02-23 P110013-S107 Resolute Integrity RX Zotarolimus-Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-02-18 P190008-S010 IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter Normal 180 Day Track No User Fee PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2021-02-18 P160043-S039 Resolute Onyx Zotarolimus-Eluting Coronary Stent System Real-Time Process NIQ Coronary Drug-Eluting Stent Unknown
2021-02-04 P190008-S009 IN.PACT AV Paclitaxel-Coated PTA Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2021-02-04 P160043-S042 Resolute Onyx Zotarolimus-Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-02-04 P110013-S106 Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-01-21 P140018-S021 VenaSeal Closure System Real-Time Process PJQ — —
2021-01-04 P110023-S031 EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2021-01-04 P060001-S031 Protege GPS Self-Expanding Peripheral Stent System 30-Day Notice NIM — —
2020-12-21 P160043-S040 Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2020-12-21 P110013-S105 Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2020-11-24 P190008-S008 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2020-10-30 P100021-S085 Talent Occluder 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-10-21 P200026 Abre Venous Self-expanding Stent System Original QAN Stent, Iliac Vein Unknown
2020-10-21 P100021-S082 Endurant II/IIs Stent Graft System Real-Time Process MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-10-21 P100021-S077 Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System 135 Review Track For 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-10-15 P100021-S084 Endurant, Endurant II, and Endurant IIs Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-10-14 P190008-S006 IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2020-10-05 P160043-S037 Resolute Onyx Coronary Stent System Normal 180 Day Track No User Fee NIQ Coronary Drug-Eluting Stent Unknown
2020-10-05 P110013-S103 Resolute Integrity Rapid Exchange Coronary Stent System Normal 180 Day Track No User Fee NIQ Coronary Drug-Eluting Stent Unknown
2020-10-05 P100040-S041 Valiant Navion Thoracic Stent Graft System Normal 180 Day Track No User Fee MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-10-05 P100021-S083 Endurant II/IIs Stent Graft System Normal 180 Day Track No User Fee MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-09-25 P160043-S038 Resolute Onyx Zotarolimus-Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2020-09-25 P110013-S104 Resolute Integrity Zotarolimus-Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2020-09-24 P190008-S004 IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter Real-Time Process PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2020-09-22 P160043-S034 Resolute Onyx Zotarolimus-Eluting Coronary Stent System Panel Track NIQ Coronary Drug-Eluting Stent Unknown
2020-09-21 P140018-S020 VenaSeal Closure System 30-Day Notice PJQ — —
2020-09-11 P190008-S005 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter Normal 180 Day Track No User Fee PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2020-08-18 P110023-S030 EverFlex Self-Expanding Peripheral Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2020-08-18 P060001-S030 Protégé GPS Self-Expanding Peripheral Stent System 30-Day Notice NIM — —
2020-08-04 P110023-S029 EverFlex Self-expanding Peripheral Stent System (SFA/PPA) and EverFlex Self-expanding Peripheral Stent System (iliac) Real-Time Process NIP Stent, Superficial Femoral Artery Unknown
2020-08-04 P060001-S029 Protege GPS Self-expanding Peripheral Stent System Real-Time Process NIM — —
2020-07-23 P100040-S040 Valiant Thoracic Stent Graft with Captiva Delivery System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-07-23 P100021-S081 Endurant, Endurant II, and Endurant IIs Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-06-25 P190008-S003 IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter Normal 180 Day Track No User Fee PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2020-05-28 P160043-S032 Resolute Onyx Zotarolimus-Eluting Coronary Stent System Normal 180 Day Track NIQ Coronary Drug-Eluting Stent Unknown
2020-04-30 P160043-S035 Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2020-04-30 P110013-S102 Resolute Integrity Zotarolimus-Eluting Coronary Stent System - RX and OTW 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2020-04-10 P190008-S001 IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter Normal 180 Day Track No User Fee PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2020-04-10 P140018-S019 VenaSeal Closure System Special (Immediate Track) PJQ — —
2020-04-09 P160043-S031 Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems Real-Time Process NIQ Coronary Drug-Eluting Stent Unknown
2020-04-02 P100021-S080 Endurant, Endurant II, and Endurant lls Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-03-24 P160043-S033 Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2020-03-24 P110013-S101 Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2020-02-20 P190008-S002 In.Pact AV Paclitaxel-Coated PTA Balloon Catheter 30-Day Notice PRC Drug-Coated Peripheral Transluminal Angioplasty Catheter Unknown
2020-02-14 P160043-S027 Resolute Onyx Zotarolimus-Eluting Coronary Stent System Normal 180 Day Track No User Fee NIQ Coronary Drug-Eluting Stent Unknown
2020-01-25 P140018-S018 VenaSeal Closure System Normal 180 Day Track PJQ — —
2020-01-09 P100021-S079 Endurant, Endurant II and Endurant IIs Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
Safety

Recalls (18)

Class I (serious)
5
Risk of injury / death
Total recalls
18
Currently ongoing
9
Most recent
2022-03-23
DateSeverityStatusRecall # ProductCodeReason
2022-03-23 Class II Ongoing Z-1043-2022 Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only — Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
2022-03-23 Class II Ongoing Z-1042-2022 Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:A… — Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
2021-12-21 Class II Ongoing Z-0657-2022 Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C… — Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of t…
2021-10-15 Class II Ongoing Z-0292-2022 Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE … — Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
2021-10-15 Class II Ongoing Z-0291-2022 Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE ST… — Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
2021-10-15 Class II Ongoing Z-0290-2022 Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE — During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
2021-06-07 Class II Ongoing Z-2136-2021 Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C1… — During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of th…
2021-06-07 Class II Ongoing Z-2135-2021 Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49… — During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
2021-05-04 Class I Terminated Z-1860-2021 Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire c… — The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to cu…
2021-04-28 Class II Terminated Z-1976-2021 Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms. — Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
2021-02-12 Class I Ongoing Z-1201-2021 Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA). — Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.
2021-01-15 Class II Terminated Z-1248-2021 Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30 — Sterility may be compromised due to an unsealed pouch
2021-01-15 Class II Terminated Z-1247-2021 Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375 — Sterility may be compromised due to an unsealed pouch
2021-01-15 Class II Terminated Z-1246-2021 Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40 — Sterility may be compromised due to an unsealed pouch
2021-01-15 Class II Terminated Z-1245-2021 Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35 — Sterility may be compromised due to an unsealed pouch
2020-08-25 Class I Terminated Z-0089-2021 Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 0061… — Subsequent failure of catheters in the field and failed quality testing
2020-08-25 Class I Terminated Z-0088-2021 Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007160 GTIN: 0061… — Subsequent failure of catheters in the field and failed quality testing
2020-08-25 Class I Terminated Z-0087-2021 Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 00… — Subsequent failure of catheters in the field and failed quality testing
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2023-10-24 K232570 Steerant™ Super Stiff Guidewire DQX Class II Cardiovascular
2023-08-22 K232190 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter DQY — —
2023-06-30 K230156 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter DQY — —
2022-04-13 K220773 Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P) MAV — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence