Chrysalis Intelligence · Sponsors · Cordis US Corp

Cordis US Corp

Miami Lakes, FL, US · 4 510(k) clearances · 99 PMAs · 22 recalls (15 Class I)

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Total clearances
4
2022-08-22 → 2024-06-28
Last 12 months
0
Product codes
4
Most recent
2024-06-28
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DQY Catheter, Percutaneous Class II Cardiovascular 1 2024-06-28
DQO Catheter, Intravascular, Diagnostic Class II Cardiovascular 1 2023-11-21
DYB Introducer, Catheter Class II Cardiovascular 1 2023-04-24
LIT Catheter, Angioplasty, Peripheral, Transluminal Class II Cardiovascular 1 2022-08-22
Class III

PMA approvals (99)

Total PMA records
99
Originals + supplements
Distinct product codes
7
First decision
2020-03-17
Most recent
2026-06-23
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-06-23 P100013-S034 Exoseal Vascular Closure Device Special (Immediate Track) MGB Device, Hemostasis, Vascular Unknown
2026-06-05 P030047-S055 PRECISE PRO RX Nitinol Stent System Special (Immediate Track) NIM Stent, Carotid Unknown
2026-05-14 P040044-S113 Cordis Mynx Vascular Closure Portfolio (VCP): MynxGrip, Mynx Control, and Mynx Control Venous Vascular Closure Special (Immediate Track) MGB Device, Hemostasis, Vascular Unknown
2026-03-31 P040044-S111 Mynx Control Vascular Closure Device (5F, 6F/7F) 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2026-01-08 P120002-S034 S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent Systems; S.M.A.R.T. RADIANZ™ Vascular Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2026-01-08 P100013-S033 EXOSEAL® Vascular Closure Device 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2026-01-08 P030047-S053 PRECISE® PRO RX Nitinol Stent System; PRECISE® PRO Transcarotid Stent System 30-Day Notice NIM Stent, Carotid Unknown
2026-01-08 P020036-S059 S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent System; S.M.A.R.T. RADIANZ™ Vascular Stent System 30-Day Notice NIO Stent, Iliac Unknown
2026-01-06 P100013-S032 EXOSEAL® Vascular Closure Device 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2025-12-04 P120002-S033 S.M.A.R.T. and S.M.A.R.T.® CONTROL® Vascular Stent Systems 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2025-12-04 P020036-S058 S.M.A.R.T.® CONTROL® Nitinol Stent System 30-Day Notice NIO Stent, Iliac Unknown
2025-10-21 P030047-S052 PRECISE® PRO Rx Nitinol Stent System; PRECISE® PRO Transcarotid Stent System 30-Day Notice NIM Stent, Carotid Unknown
2025-09-12 P120002-S032 S.M.A.R.T.® CONTROL® Vascular Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2025-09-12 P030047-S051 PRECISE® PRO RX Nitinol Stent System; PRECISE® PRO Transcarotid Stent System 30-Day Notice NIM Stent, Carotid Unknown
2025-09-12 P020036-S057 S.M.A.R.T.® CONTROL® Nitinol Stent System 30-Day Notice NIO Stent, Iliac Unknown
2025-07-23 P040044-S110 MynxGrip Vascular Closure Device (5F, 6F/7F); Mynx Control Vascular Closure Device (5F, 6F/7F); Mynx Control Venous Vasc 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2025-07-11 P100013-S031 EXOSEAL Vascular Closure Device 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2025-05-28 P120002-S030 SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS Special (Immediate Track) NIP Stent, Superficial Femoral Artery Unknown
2025-05-28 P020036-S055 S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM Special (Immediate Track) NIO Stent, Iliac Unknown
2025-05-15 P150002-S012 INCRAFT® AAA Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-05-15 P120002-S031 S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent Systems, S.M.A.R.T. RADIANZ™ Vascular Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2025-05-15 P100013-S030 EXOSEAL® Vascular Closure Device 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2025-05-15 P020036-S056 S.M.A.R.T.® CONTROL® Nitinol Stent System, S.M.A.R.T. RADIANZTM Vascular Stent System 30-Day Notice NIO Stent, Iliac Unknown
2025-05-09 P040044-S109 Mynx Control Vascular Closure Device Special (Immediate Track) MGB Device, Hemostasis, Vascular Unknown
2025-04-24 P100013-S029 Exoseal Vascular Closure Device Special (Immediate Track) MGB Device, Hemostasis, Vascular Unknown
2025-04-09 P150002-S011 INCRAFT AAA Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2025-04-09 P120002-S029 S.M.A.R.T.; S.M.A.R.T. CONTROL Vascular Stent Systems; S.M.A.R.T. RADIANZ Vascular Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2025-04-09 P020036-S054 S.M.A.R.T. CONTROL Nitinol Stent System; S.M.A.R.T. RADIANZ Vascular Stent System 30-Day Notice NIO Stent, Iliac Unknown
2025-04-04 P030047-S049 PRECISE PRO RX Transcarotid Stent System Panel Track NIM Stent, Carotid Unknown
2024-12-18 P120002-S028 S.M.A.R.T. RADIANZ Vascular Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2024-12-18 P030047-S050 PRECISE Nitinol Stent System 30-Day Notice NIM Stent, Carotid Unknown
2024-12-18 P020036-S053 S.M.A.R.T. RADIANZ Vascular Stent System 30-Day Notice NIO Stent, Iliac Unknown
2024-12-09 P040044-S108 Mynx Control Vascular Control Device, Mynx Control Venous Vascular Control Device 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2024-11-21 P040044-S107 MynxGrip Vascular Closure Device (5F, 6F/7F), Mynx Control Vascular Closure Device (5F, 6F/7F) 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2024-11-15 P040044-S106 MYNXGRIP Vascular Closure Device (5F, 6F/7F), MYNX CONTROL Vascular Closure Device (5F, 6F/7F), MYNX CONTROL VENOUS Vasc 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2024-11-15 P040044-S105 MynxGrip Vascular Closure Device (5F, 6F/7F), Mynx Control Vascular Closure Device (5F, 6F/7F), Mynx Control Venous Vasc 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2024-10-25 P120002-S027 The S.M.A.R.T. CONTROL / S.M.A.R.T. Vascular Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2024-10-25 P030047-S048 PRECISE PRO Rx Nitinol Stent System 30-Day Notice NIM Stent, Carotid Unknown
2024-10-25 P020036-S052 S.M.A.R.T. CONTROL Vascular Stent System, S.M.A.R.T. RADIANZ Vascular Stent System 30-Day Notice NIO Stent, Iliac Unknown
2024-10-09 P040044-S104 MynxGrip Vascular Closure Device (5F, 6F/7F) Special (Immediate Track) MGB Device, Hemostasis, Vascular Unknown
2024-09-13 P040044-S103 MYNXGRIP Vascular Closure Device, MYNX CONTROL Vascular Closure Device 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2024-09-05 P220004-S002 PALMAZ MULLINS XD Pulmonary Stent 30-Day Notice QWC Pulmonary Stent Unknown
2024-08-20 P040044-S102 MynxGrip Vascular Closure Device (5F, 6F/7F), Mynx Control Vascular Closure Device (5F, 6F/7F) 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2024-06-27 P040044-S097 MYNX CONTROL™ Venous Vascular Closure Device (VCD) 6F-12F Panel Track MGB Device, Hemostasis, Vascular Unknown
2024-04-12 P040044-S101 MynxGrip Vascular Closure Device (5F, 6F/7F), Mynx Control Vascular Closure Device (5F, 6F/7F) 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2024-03-21 P040044-S100 Mynx Control Vascular Closure Device (5F, 6F/7F), MynxGrip Vascular Closure Device (5F, 6F/7F) 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2024-03-06 P040044-S099 MynxGrip Vascular Closure Device (5F, 6F/7F) 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2023-12-23 P100013-S027 EXOSEAL Vascular Closure Device Normal 180 Day Track No User Fee MGB Device, Hemostasis, Vascular Unknown
2023-12-11 P040044-S096 MynxGrip Vascular Closure Device and Mynx Control Vascular Closure Device (VCD) 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2023-11-02 P220004-S001 PALMAZ MULLINS XD Pulmonary Stent Normal 180 Day Track No User Fee QWC Pulmonary Stent Unknown
2023-10-31 P100013-S028 Cordis® EXOSEAL® Vascular Closure Device 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2023-10-17 P040044-S095 MynxGrip and Mynx Control Vascular Closure Device 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2023-09-28 P120002-S025 Cordis® S.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent System,Cordis® S.M.A.R.T. RADIANZTM Vascular Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2023-09-28 P020036-S050 Cordis® S.M.A.R.T.® CONTROL® Vascular Stent System, Cordis® S.M.A.R.T. RADIANZTM Vascular Stent System 30-Day Notice NIO Stent, Iliac Unknown
2023-07-27 P120002-S024 Cordis® S.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent System, Cordis® S.M.A.R.T. RADIANZ Vascular Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2023-07-27 P030047-S047 Cordis® PRECISE® Nitinol Stent System 30-Day Notice NIM Stent, Carotid Unknown
2023-07-27 P020036-S049 `Cordis® S.M.A.R.T.® CONTROL Vascular Stent System, Cordis® S.M.A.R.T. RADIANZ TM Vascular Stent System 30-Day Notice NIO Stent, Iliac Unknown
2023-07-21 P220004 PALMAZ MULLINS XD Pulmonary Stent Original QWC Pulmonary Stent Unknown
2023-07-13 P040044-S094 Mynx Control Vascular Control Device (5F, 6F/7F) Real-Time Process MGB Device, Hemostasis, Vascular Unknown
2023-04-20 P120002-S021 S.M.A.R.T. RADIANZ™ Vascular Stent System 135 Review Track For 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2023-04-20 P020036-S046 S.M.A.R.T. RADIANZ™ Vascular Stent System 135 Review Track For 30-Day Notice NIO Stent, Iliac Unknown
2023-02-13 P100013-S025 Cordis® EXOSEAL® Vascular Closure Device Normal 180 Day Track No User Fee MGB Device, Hemostasis, Vascular Unknown
2022-12-20 P890017-S023 Cordis® PALMAZ® Balloon-Expandable Stent Real-Time Process NIO Stent, Iliac Unknown
2022-12-16 P120002-S023 Cordis® S.M.A.R.T.® CONTROL® Nitinol Stent Systems, Cordis® S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent Systems 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2022-12-16 P030047-S046 Cordis® PRECISE® Nitinol Stent Systems 30-Day Notice NIM Stent, Carotid Unknown
2022-12-16 P020036-S048 Cordis® S.M.A.R.T.® CONTROL® Nitinol Stent Systems, Cordis® S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent Systems, 30-Day Notice NIO Stent, Iliac Unknown
2022-12-07 P120002-S022 Cordis® S.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2022-12-07 P030047-S045 Cordis® PRECISE® Nitinol Stent System 30-Day Notice NIM Stent, Carotid Unknown
2022-12-07 P020036-S047 Cordis® S.M.A.R.T.® CONTROL® Vascular Stent System 30-Day Notice NIO Stent, Iliac Unknown
2022-10-28 P100013-S026 EXOSEAL® Vascular Closure Device 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2022-10-27 P040044-S093 MynxGrip Vascular Closure Device and two components of Mynx Control Vascular Closure Device (VCD) 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2022-06-27 P040044-S092 MynxGrip Vascular Closure Device, Mynx Control Vascular Closure Device (VCD) 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2022-04-27 P030047-S044 Cordis PRECISE Nitinol Stent System 30-Day Notice NIM Stent, Carotid Unknown
2022-04-25 P040044-S091 MYNX Vascular Closure Device 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2022-03-08 P890017-S022 Cordis® PALMAZ® Balloon-Expandable Stent Real-Time Process NIN Stent, Renal Unknown
2022-03-01 P100013-S024 Cordis® Exoseal® Vascular Closure Device 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2022-02-25 P120002-S020 S.M.A.R.T. RADIANZ Vascular Stent System Normal 180 Day Track NIP Stent, Superficial Femoral Artery Unknown
2022-02-25 P020036-S045 S.M.A.R.T. RADIANZ Vascular Stent System Normal 180 Day Track NIO Stent, Iliac Unknown
2022-02-11 P030047-S043 Cordis® PRECISE® Nitinol Stent System Special (Immediate Track) NIM Stent, Carotid Unknown
2021-12-15 P100013-S023 Cordis® EXOSEAL® Vascular Closure Device 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2021-12-13 P040044-S090 MynxGrip Vascular Closure Device (SF, 6F/7F), Mynx Control Vascular Closure Device (SF, 6F/7F) 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2021-11-10 P040044-S089 MynxGrip Vascular Closure Device (SF, 6F/7F) ; Mynx Control Vascular Closure Device (SF, 6F/7F) 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2021-11-05 P040044-S088 Mynx Control and Mynx Grip Vascular Closure Device 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2021-11-03 P040044-S087 MynxGrip Vascular Closure Device (VCD) 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2021-11-02 P100013-S022 Exoseal® Vascular Closure Device 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2021-09-29 P040044-S086 Mynx Control Vascular Closure Device (VCD) 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2021-09-28 P100013-S021 CORDIS EXOSEAL VASCULAR CLOSURE DEVICE 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2021-05-26 P150002-S010 INCRAFT AAA Stent Graft System 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2021-04-01 P120002-S019 Cordis S.M.A.R.T. CONTROL / S.M.A.R.T. Vascular Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2021-04-01 P030047-S042 Cordis PRECISE Nitinol Stent System 30-Day Notice NIM Stent, Carotid Unknown
2021-04-01 P030047-S041 PRECISE Pro Rx Nitinol Stent System Special (Immediate Track) NIM Stent, Carotid Unknown
2021-04-01 P020036-S044 Cordis S.M.A.R.T. CONTROL Nitinol Stent System 30-Day Notice NIO Stent, Iliac Unknown
2020-10-23 P120002-S018 Cordis S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2020-10-23 P020036-S043 Cordis S.M.A.R.T. CONTROL Nitinol Stent System 30-Day Notice NIO Stent, Iliac Unknown
2020-09-23 P150002-S008 INCRAFT(R) AAA STENT GRAFT SYSTEM Normal 180 Day Track No User Fee MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
2020-05-29 P120002-S017 Cordis S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent System 30-Day Notice NIP Stent, Superficial Femoral Artery Unknown
2020-05-29 P030047-S040 Cordis PRECISE Nitinol Stent System 30-Day Notice NIM Stent, Carotid Unknown
2020-05-29 P020036-S042 Cordis S.M.A.R.T. CONTROL Nitinol Stent System 30-Day Notice NIO Stent, Iliac Unknown
2020-03-17 P150002-S007 INCRAFT AAA Stent Graft System 135 Review Track For 30-Day Notice MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown
Safety

Recalls (22)

Class I (serious)
15
Risk of injury / death
Total recalls
22
Currently ongoing
22
Most recent
2025-03-04
DateSeverityStatusRecall # ProductCodeReason
2025-03-04 Class II Ongoing Z-1511-2025 Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only — product mix-up; Vascular stent labeled as one size but contains a different size.
2025-03-04 Class II Ongoing Z-1510-2025 Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only — product mix-up; Vascular stent labeled as one size but contains a different size.
2025-02-07 Class II Ongoing Z-1330-2025 Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for int… — Catheter manufactured at the incorrect length.
2023-11-28 Class II Ongoing Z-0675-2024 MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites — Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 …
2023-11-28 Class II Ongoing Z-0674-2024 MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites. — Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 …
2023-09-26 Class I Ongoing Z-0286-2024 Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter — Non-sterile product labeled as sterile was distributed.
2023-03-24 Class I Ongoing Z-1496-2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE — There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-pr…
2023-03-24 Class I Ongoing Z-1495-2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM — There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-pr…
2023-03-24 Class I Ongoing Z-1494-2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM — There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-pr…
2023-03-24 Class I Ongoing Z-1493-2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE — There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-pr…
2023-03-24 Class I Ongoing Z-1492-2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE — There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-pr…
2023-03-24 Class I Ongoing Z-1491-2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE — There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-pr…
2023-03-24 Class I Ongoing Z-1490-2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM — There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-pr…
2023-03-24 Class I Ongoing Z-1489-2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC — There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-pr…
2023-03-24 Class I Ongoing Z-1488-2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC — There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-pr…
2023-03-24 Class I Ongoing Z-1487-2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC — There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-pr…
2023-03-24 Class I Ongoing Z-1486-2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC — There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-pr…
2023-03-24 Class I Ongoing Z-1485-2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC — There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-pr…
2023-03-24 Class I Ongoing Z-1484-2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC — There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-pr…
2023-03-24 Class I Ongoing Z-1483-2023 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC — There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-pr…
2022-11-07 Class II Ongoing Z-0720-2023 Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for inject… — There is a potential for separation at the male connector.
2022-05-20 Class II Ongoing Z-1363-2022 PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG399… — Potential for stent dislodgement and associated failures related to two specific sizes of the device.
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2024-06-28 K233637 Cordis BRITECROSS Support Catheter DQY Class II Cardiovascular
2023-11-21 K232573 INFINITI™ Ambi Angiographic Catheter DQO Class II Cardiovascular
2023-04-24 K230704 RAIN Sheath™ Tibial Pedal Introducer DYB Class II Cardiovascular
2022-08-22 K221832 SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter LIT Class II Cardiovascular
Data source: openFDA · Generated 2026-09-07 09:19 · Last ingest 2026-09-07T13:19:27.426703 · Pipeline: Chrysalis Intelligence