Chrysalis Intelligence · Sponsors · Abbott Vascular

Abbott Vascular

Santa Clara, CA, US · 4 510(k) clearances · 112 PMAs · 32 recalls (18 Class I)

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Total clearances
4
2020-04-08 → 2022-06-30
Last 12 months
0
Product codes
3
Most recent
2022-06-30
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DQX Wire, Guide, Catheter Class II Cardiovascular 2 2020-07-30
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Class II Cardiovascular 1 2022-06-30
LIT Catheter, Angioplasty, Peripheral, Transluminal Class II Cardiovascular 1 2022-05-05
Class III

PMA approvals (112)

Total PMA records
112
Originals + supplements
Distinct product codes
7
First decision
2020-02-13
Most recent
2026-09-24
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-09-24 P960043-S137 Perclose ProGlide Suture-Mediated Closure System; Perclose ProStyle Suture-Mediated Closure and Repair System 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2026-08-28 P110019-S144 XIENCE PROS Everolimus Eluting Coronary Stent System (XIENCE PRO5); XIENCE Skypoint Everolimus Eluting Coronary Stent Sy 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2026-08-27 P960043-S128 Perclose ProGlide Suture-Mediated Closure System and Perclose ProStyle Suture-Mediated Closure and Repair System Real-Time Process MGB Device, Hemostasis, Vascular Unknown
2026-07-31 P110019-S142 XIENCE Alpine; XIENCE Sierra; XIENCE PROs; XIENCE Skypoint Everolimus Eluting Coronary Stent Systems Real-Time Process NIQ Coronary Drug-Eluting Stent Unknown
2026-07-14 P960043-S136 Perclose ProStyle Suture-Mediated Closure and Repair System 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2026-05-22 P960043-S134 Perclose ProGlide Suture-Mediated Closure System; Perclose ProStyle Suture-Mediated Closure and Repair System 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2026-05-22 P110019-S141 XIENCE Alpine™, XIENCE Sierra™, XIENCE PRO™ S, and XIENCE Skypoint™ Everolimus Eluting Coronary Stent Systems 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2026-04-17 P960043-S133 Perclose ProGlide™ Suture-Mediated Closure System; Perclose™ ProStyle™ Suture-Mediated Closure and Repair System 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2026-04-01 P960043-S132 Perclose ProGlide Suture-Mediated Closure System; Perclose ProStyle Suture-Mediated Closure and Repair System 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2026-03-20 P040038-S051 XACT™ Carotid Stent System 30-Day Notice NIM Stent, Carotid Unknown
2026-03-02 P960043-S131 Perclose ProGlide™ Suture-Mediated Closure System; Perclose™ ProStyle™ Suture-Mediated Closure and Repair System 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2026-02-13 P110019-S140 XIENCE Alpine Everolimus Eluting Coronary Stent System; XIENCE Sierra Everolimus Eluting Coronary Stent System; XIENCE P 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2026-02-11 P960043-S130 Perclose ProGuide Suture-Mediated Closure System; Perclose ProStyle Suture-Mediated Closure and Repair System 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2026-02-10 P960043-S129 Perclose™ ProGlide Suture-Mediated Closure System; Perclose™ ProStyle Suture-Mediated Closure and Repair System 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2026-02-05 P110019-S139 XIENCE Alpine Everolimus Eluting Coronary Stent System (XIENCE Alpine); XIENCE Sierra Everolimus Eluting Coronary Stent 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2026-02-03 P110019-S138 XIENCE Alpine Everolimus Eluting Coronary Stent System (XIENCE Alpine), XIENCE Sierra Everolimus Eluting Coronary Stent 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2025-12-09 P960043-S127 Perclose ProGlide® Suture-Mediated Closure System; Prostar® XL Percutaneous Vascular Surgical System Normal 180 Day Track No User Fee MGB Device, Hemostasis, Vascular Unknown
2025-12-09 P040038-S048 XACT® Carotid Stent System Normal 180 Day Track No User Fee NIM Stent, Carotid Unknown
2025-10-22 P110028-S025 Absolute Pro Vascular 30-Day Notice NIO Stent, Iliac Unknown
2025-10-22 P110019-S137 XIENCE Alpine™ Everolimus Eluting Coronary Stent System (XIENCE Alpine OTW) 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2025-10-22 P110001-S022 RX Herculink Elite 30-Day Notice NIN Stent, Renal Unknown
2025-10-22 P040012-S066 RX Acculink 30-Day Notice NIM Stent, Carotid Unknown
2025-10-17 P040038-S050 XACT Carotid Stent System (XACT CSS) and XACT Transcarotid Stent System (XACT TSS) 30-Day Notice NIM Stent, Carotid Unknown
2025-08-25 P040038-S049 XACT Carotid Stent System 30-Day Notice NIM Stent, Carotid Unknown
2025-08-16 P110019-S136 XIENCE Alpine™ Everolimus Eluting Coronary Stent System (XIENCE Alpine); XIENCE Sierra™ Everolimus Eluting Coronary Sten 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2025-07-22 P110028-S024 Absolute Pro Vascular Self-Expanding Stent System 30-Day Notice NIO Stent, Iliac Unknown
2025-07-02 P110001-S021 RX HERCULINK ELITE RENAL STENT SYSTEM 30-Day Notice NIN Stent, Renal Unknown
2025-05-19 P110019-S135 Xience Skypoint Everolimus Eluting Coronary Stent System; XIENCE Alpine Everolimus Coronary Stent System; XIENCE Sierra Real-Time Process NIQ Coronary Drug-Eluting Stent Unknown
2025-03-09 P960043-S125 Perclose ProGlide Suture-Mediated Closure System, Prostar XL Percutaneous Vascular Surgical System Normal 180 Day Track No User Fee MGB Device, Hemostasis, Vascular Unknown
2025-03-09 P040038-S047 XACT Carotid Stent System Normal 180 Day Track No User Fee NIM Stent, Carotid Unknown
2025-02-24 P960043-S126 Perclose ProGlide Suture-Mediated Closure (SMC) System; Perclose ProStyle Suture-Mediated Closure and Repair (SMCR) Syst 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2025-02-20 P040012-S065 RX Acculink Carotid Stent System 30-Day Notice NIM Stent, Carotid Unknown
2025-02-10 P960043-S124 Perclose ProGlide® Suture-Mediated Closure System, Prostar® XL Percutaneous Vascular Surgical System Normal 180 Day Track No User Fee MGB Device, Hemostasis, Vascular Unknown
2025-02-10 P040038-S046 XACT® Carotid Stent System Normal 180 Day Track No User Fee NIM Stent, Carotid Unknown
2024-10-24 P110019-S134 XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2024-09-20 P110019-S133 XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2024-07-25 P960043-S123 Prostar XL Percutaneous Vascular Surgical System 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2024-07-15 P040038-S045 XACT Transcarotid Stent System (XACT TSS) Real-Time Process NIM Stent, Carotid Unknown
2024-05-20 P960043-S122 Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Suture-Mediated Closure and Repair System 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2024-02-15 P110019-S132 XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2024-02-07 P040038-S043 XACT Carotid Stent System Panel Track NIM Stent, Carotid Unknown
2024-01-17 P110019-S131 XIENCE PRIME™ Everolimus Eluting Coronary Stent System, XIENCE Xpedition™ Everolimus Eluting Coronary Stent System, XIEN 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2024-01-17 P040038-S044 XACT™ Carotid Stent System 30-Day Notice NIM Stent, Carotid Unknown
2023-12-15 P110019-S130 Xience Skypoint Everolimus Eluting Coronary Stent System (XIENCE Skypoint) , XIENCE PROs Everolimus Eluting Coronary Ste 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2023-12-14 P960043-S121 Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Suture-Mediated Closure and Repair System 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2023-11-21 P110019-S129 XIENCE Sierra Everolimus Eluting Coronary Stent System (XIENCE Sierra), XIENCE Skypoint Everolimus Eluting Coronary Sten 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2023-10-27 P110019-S128 XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2023-10-04 P110019-S124 XIENCE Skypoint Everolimus Eluting Coronary Stent System Normal 180 Day Track NIQ Coronary Drug-Eluting Stent Unknown
2023-07-20 P110019-S125 Xience Skypoint Everolimus Eluting Coronary Stent System Normal 180 Day Track No User Fee NIQ Coronary Drug-Eluting Stent Unknown
2023-07-14 P110019-S127 XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2023-06-14 P110019-S126 XIENCE Alpine™ Everolimus Eluting Coronary Stent System (XIENCE Alpine) 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2023-06-14 P110001-S020 RX Herculink Elite Renal and Biliary Stent System 30-Day Notice NIN Stent, Renal Unknown
2023-06-14 P040038-S042 XACT Carotid Stent System 30-Day Notice NIM Stent, Carotid Unknown
2023-06-14 P020047-S076 MULTI-LINK VISION® RX Coronary Stent System, MULTI-LINK MINI VISION® RX Coronary Stent System 30-Day Notice MAF Stent, Coronary Unknown
2023-06-12 P020047-S077 MULTI-LINK VISION RX Coronary Stent System, MULTI-LINK MINI VISION Coronary Stent System 30-Day Notice MAF Stent, Coronary Unknown
2023-06-02 P960043-S118 Perclose ProStyle Suture-Mediated Closure and Repair System, Perclose ProGlide Suture-Mediated Closure System Panel Track MGB Device, Hemostasis, Vascular Unknown
2023-04-05 P110019-S123 XIENCE PROS Everolimus Eluting Coronary Stent System Normal 180 Day Track No User Fee NIQ Coronary Drug-Eluting Stent Unknown
2023-01-31 P960043-S120 Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Suture-Mediated Closure and Repair System, Prostar X 135 Review Track For 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2023-01-31 P110028-S023 Absolute Pro Vascular Self-Expanding Stent System 135 Review Track For 30-Day Notice NIO Stent, Iliac Unknown
2023-01-31 P040038-S041 XACT Carotid Stent System 135 Review Track For 30-Day Notice NIM Stent, Carotid Unknown
2023-01-31 P040012-S064 RX Acculink Carotid Stent System 135 Review Track For 30-Day Notice NIM Stent, Carotid Unknown
2022-12-16 P960043-S119 Prostar™ XL Percutaneous Vascular Surgical System, Perclose ProGlide™ Suture-Mediated Closure System, Perclose™ ProStyle 30-Day Notice — — —
2022-09-14 P110019-S122 XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S Real-Time Process NIQ Coronary Drug-Eluting Stent Unknown
2022-09-07 P970020-S086 MULTI-LINK RX ULTRA™ Coronary Stent System 30-Day Notice MAF Stent, Coronary Unknown
2022-09-07 P020047-S075 MULTI-LINK VISION™ RX Coronary Stent System, MULTI-LINK VISION™ RX 2.75 mm Coronary Stent System, MULTI-LINK MINI VISION 30-Day Notice MAF Stent, Coronary Unknown
2022-08-23 P960043-S117 Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Suture-Mediated Closure and Repair System 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2022-07-14 P960043-S116 Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Suture-Mediated Closure and Repair System 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2022-07-13 P040038-S040 XACT Carotid Stent System 30-Day Notice NIM Stent, Carotid Unknown
2022-06-22 P110019-S121 XIENCE Skypoint Everolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2022-05-06 P110019-S120 XIENCE Skypoint Everolimus Eluting Coronary Stent System Normal 180 Day Track No User Fee NIQ Coronary Drug-Eluting Stent Unknown
2022-03-24 P110001-S018 RX Herculink Elite Renal Stent System 30-Day Notice NIN Stent, Renal Unknown
2022-03-11 P110019-S118 XIENCE Skypoint Everolimus Eluting Coronary Stent System Normal 180 Day Track NIQ Coronary Drug-Eluting Stent Unknown
2021-12-08 P110001-S017 RX Herculink Elite Renal Stent System 30-Day Notice NIN Stent, Renal Unknown
2021-12-08 P040038-S039 XACT Carotid Stent System 30-Day Notice NIM Stent, Carotid Unknown
2021-12-08 P040012-S063 RX Acculink Carotid Stent System 30-Day Notice NIM Stent, Carotid Unknown
2021-11-24 P040038-S038 XACT Carotid Stent System 30-Day Notice NIM Stent, Carotid Unknown
2021-11-19 P110019-S119 XIENCE PRIME, XIENCE PRIME LL Everolimus Eluting Coronary Stent Systems; XIENCE Xpedition, XIENCE Xpedition SV, XIENCE X 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-10-27 P960043-S115 Perclose ProStyle Suture-Mediated Closure and Repair System 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2021-10-26 P110001-S016 RX Herculink Elite Renal and Biliary Stent System 30-Day Notice NIN Stent, Renal Unknown
2021-10-12 P110028-S022 ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM 30-Day Notice NIO Stent, Iliac Unknown
2021-10-12 P040012-S062 ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM 30-Day Notice NIM Stent, Carotid Unknown
2021-09-24 P960043-S112 Perclose ProGlide Suture-Mediated Closure System Real-Time Process MGB Device, Hemostasis, Vascular Unknown
2021-09-22 P960043-S114 Perclose ProGlide Suture-Mediated Closure System 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2021-09-07 P960043-S113 Perclose ProStyle Suture-Mediated Closure and Repair System 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2021-07-30 P110019-S117 XIENCE Skypoint Everolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-06-25 P110019-S115 XIENCE Alpine Everolimus Eluting Coronary Stent Systems (XIENCE Alpine EECSS), XIENCE Sierra Everolimus Eluting Coronary Panel Track NIQ Coronary Drug-Eluting Stent Unknown
2021-06-22 P110001-S015 RX Herculink Elite Renal and Biliary Stent System 30-Day Notice NIN Stent, Renal Unknown
2021-06-21 P970020-S085 Multi-Link RX Ultra Coronary Stent System 30-Day Notice MAF Stent, Coronary Unknown
2021-06-21 P110001-S014 RX Herculink Elite Renal and Biliary Stent System 30-Day Notice NIN Stent, Renal Unknown
2021-06-16 P040012-S061 Acculink Carotid Stent System 30-Day Notice NIM Stent, Carotid Unknown
2021-05-13 P110019-S113 XIENCE Skypoint Everolimus Eluting Coronary Stent System Normal 180 Day Track NIQ Coronary Drug-Eluting Stent Unknown
2021-03-24 P110019-S116 XIENCE PRIME SV Everolimus Eluting Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, XIENCE 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-03-24 P070015-S148 XIENCE V Everolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2021-03-24 P020047-S074 MULTI-LINK VISION, MULTI-LINK MINI VISION and MULTI-LINK 8 Coronary Stent Systems 30-Day Notice MAF Stent, Coronary Unknown
2021-02-26 P960043-S111 Perclose ProGlide Suture-Mediated Closure System 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2020-12-16 P110019-S114 XIENCE Sierra Everolimus Eluting Coronary Stent System Normal 180 Day Track No User Fee NIQ Coronary Drug-Eluting Stent Unknown
2020-12-04 P960043-S110 Prostar XL Percutaneous Vascular Surgical System, Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Su 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2020-10-27 P960043-S107 Perclose ProStyle Suture-Mediated Closue and Repair System Normal 180 Day Track MGB Device, Hemostasis, Vascular Unknown
2020-10-22 P110019-S112 XIENCE Sierra Stent System Real-Time Process NIQ Coronary Drug-Eluting Stent Unknown
2020-10-06 P040012-S060 Acculink Carotid Stent System 30-Day Notice NIM Stent, Carotid Unknown
2020-10-01 P960043-S109 Perclose ProGlide Suture-Mediated Closure System 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2020-09-11 P020047-S073 Multi-Link Vision RX Coronary Stent System, Multi-Link Mini Vision RX Coronary Stent System, Multi-Link 8/8SV/8LL Corona 30-Day Notice MAF Stent, Coronary Unknown
2020-09-03 P040038-S036 XACT Carotid Stent System 30-Day Notice NIM Stent, Carotid Unknown
2020-08-28 P110028-S021 Absolute Pro Vascular Self-Expanding Stent System 30-Day Notice NIO Stent, Iliac Unknown
2020-08-12 P960043-S108 Perclose ProGlide Suture-Mediated Closure System 30-Day Notice MGB Device, Hemostasis, Vascular Unknown
2020-04-06 P110019-S109 XIENCE Sierra Everolimus Eluting Coronary System Real-Time Process NIQ Coronary Drug-Eluting Stent Unknown
2020-03-19 P110019-S108 XIENCE PRIME, XIENCE PRIME SV/LL, XIENCE Xpedition, XIENCE Xpedition SV/LL, XIENCE Alpine, and XIENCE Sierra EVEROLIMUS 135 Review Track For 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2020-03-19 P070015-S146 XIENCE V and XIENCE Nano EVEROLIMUS ELUTING CORONARY STENT SYSTEMS 135 Review Track For 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2020-03-19 P020047-S072 MULTI-LINK 8, MULTI-LINK 8 SV/LL CORONARY STENT SYSTEMS 135 Review Track For 30-Day Notice MAF Stent, Coronary Unknown
2020-03-12 P110019-S111 XIENCE PRIME SV Everolimus Eluting Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, XIENCE 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2020-03-12 P070015-S147 XIENCE V Everolimus Eluting Coronary Stent System, XIENCE nano Everolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
2020-02-13 P110019-S110 Xience Sierra Everolimus Eluting Coronary Stent System 30-Day Notice NIQ Coronary Drug-Eluting Stent Unknown
Safety

Recalls (32)

Class I (serious)
18
Risk of injury / death
Total recalls
32
Currently ongoing
14
Most recent
2024-11-06
DateSeverityStatusRecall # ProductCodeReason
2024-11-06 Class II Ongoing Z-0733-2025 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular procedures. — Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
2024-11-06 Class II Ongoing Z-0732-2025 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures. — Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
2024-11-06 Class II Ongoing Z-0732-2025 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures. — Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
2024-11-06 Class II Ongoing Z-0731-2025 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interven… — Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
2024-11-06 Class II Ongoing Z-0730-2025 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such… — Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.
2022-09-08 Class II Ongoing Z-0117-2023 Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR Clinical/CDS0704-NTW, … — An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking c…
2022-09-08 Class II Ongoing Z-0116-2023 Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System CE/CDS0602-NTR, Mi… — An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking c…
2022-09-08 Class II Ongoing Z-0115-2023 Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, M… — An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking c…
2022-03-30 Class I Ongoing Z-1095-2022 Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO — There is a potential that the proximal marker may separate from the imaging catheter
2022-03-11 Class II Ongoing Z-0925-2022 Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 100018… — Due to an increase in complaint trend for leaks and intermittent/loose connections.
2022-03-11 Class II Ongoing Z-0924-2022 INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01) — Due to an increase in complaint trend for leaks and intermittent/loose connections.
2022-03-11 Class II Ongoing Z-0923-2022 20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01) — Due to an increase in complaint trend for leaks and intermittent/loose connections.
2022-03-11 Class II Ongoing Z-0922-2022 20/30 Priority Pack Accessory Kit/.096 RHV - REF 1000186 WPL2122270-01 (2019-03-01) 20/30 Priority Pack w/.115 RHV -… — Due to an increase in complaint trend for leaks and intermittent/loose connections.
2022-03-11 Class II Ongoing Z-0921-2022 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01) — Due to an increase in complaint trend for leaks and intermittent/loose connections.
2020-03-25 Class II Terminated Z-2370-2020 Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 ¿g/cm¿, Nominal Everolimus Conte… — Incorrect expiration date
2020-01-29 Class I Terminated Z-1144-2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM The NC Traveler RX Corona… — Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29 Class I Terminated Z-1143-2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM The NC Traveler RX Corona… — Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29 Class I Terminated Z-1142-2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM The NC Traveler RX Coron… — Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29 Class I Terminated Z-1141-2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X 12MM The NC Traveler RX Coron… — Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29 Class I Terminated Z-1140-2020 NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM The NC Traveler RX Corona… — Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29 Class I Terminated Z-1139-2020 NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM BDC The NC TREK RX Coronary Dil… — Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29 Class I Terminated Z-1138-2020 NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 X 15MM BDC The NC TREK RX Coronary Dila… — Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29 Class I Terminated Z-1137-2020 NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDC The NC TREK RX Coronary Dil… — Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29 Class I Terminated Z-1136-2020 NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC The NC TREK RX Coronary Dila… — Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29 Class I Terminated Z-1135-2020 NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC The NC TREK RX Coronary Dil… — Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29 Class I Terminated Z-1134-2020 NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC The NC TREK RX Coronary Dil… — Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29 Class I Terminated Z-1133-2020 NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilat… — Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29 Class I Terminated Z-1132-2020 NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dila… — Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29 Class I Terminated Z-1131-2020 NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC The NC TREK RX Coronary Dil… — Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29 Class I Terminated Z-1130-2020 NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC The NC TREK RX Coronary Dil… — Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29 Class I Terminated Z-1129-2020 NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC The NC TREK RX Coronary Dil… — Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
2020-01-29 Class I Terminated Z-1128-2020 NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDC The NC TREK RX Coronary Dila… — Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2022-06-30 K220634 NC TREK NEO Coronary Dilatation Catheter LOX Class II Cardiovascular
2022-05-05 K221057 Viatrac 14 Plus Peripheral Dilatation Catheter LIT Class II Cardiovascular
2020-07-30 K201834 HI-TORQUE PROCEED Guide Wire Family DQX Class II Cardiovascular
2020-04-08 K200144 HI-TORQUE Steelcore Bare Guide Wire DQX Class II Cardiovascular
Data source: openFDA · Generated 2026-10-06 10:35 · Last ingest 2026-10-06T14:35:17.195499 · Pipeline: Chrysalis Intelligence