Abbott Vascular
Temecula, CA, US
ABBOTT VASCULAR appears in FDA device records in Temecula, CA. FDA records list 53 510(k) clearances between and , 878 PMA records and 6 registered establishments. As of , FDA records show 78 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
5 namesFDA records resolved to Abbott Vascular carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Abbott Vascular Devices510(k), PMA, recall
- Abbott Vascular-Cardiac Therapies dba Guidant Corporationrecall
- Guidant Corporation ACSrecall
- Guidant Corporation Advanced CardiovascularSystemrecall
- Guidant Endovascular Solutions, Inc.510(k), recall
510(k) clearance history
Showing 50 of 53FDA records hold 53 510(k) clearances for Abbott Vascular between 2000 and 2022. The busiest year on record is 2009, with 6. The most recent is 2022, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 2 |
| 2003 | 2 |
| 2005 | 2 |
| 2006 | 2 |
| 2007 | 2 |
| 2008 | 3 |
| 2009 | 6 |
| 2010 | 3 |
| 2011 | 3 |
| 2012 | 5 |
| 2013 | 2 |
| 2014 | 3 |
| 2015 | 4 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 2 |
| 2022 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220634 | NC TREK NEO Coronary Dilatation Catheter | LOX | Substantially Equivalent | |
| K221057 | Viatrac 14 Plus Peripheral Dilatation Catheter | LIT | Substantially Equivalent | |
| K201834 | HI-TORQUE PROCEED Guide Wire Family | DQX | Substantially Equivalent | |
| K200144 | HI-TORQUE Steelcore Bare Guide Wire | DQX | Substantially Equivalent | |
| K193126 | HI-TORQUE InfilTrac Guide Wire Family | DQX | Substantially Equivalent | |
| K191173 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires | NTE | Substantially Equivalent | |
| K180040 | NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ II OTW Coronary Dilatation Catheter | LOX | Substantially Equivalent | |
| K173795 | HI-TORQUE TurnTrac Guide Wire Family | DQX | Substantially Equivalent | |
| K172394 | Steerable Guide Catheter | DRA | Substantially Equivalent | |
| K172073 | Hi-Torque Command 18 Guide Wire | DQX | Substantially Equivalent | |
| K161985 | Steerable Guide Catheter | DRA | Substantially Equivalent | |
| K153086 | RX ACCUNET Embolic Protection System | NTE | Substantially Equivalent | |
| K152709 | HI-TORQUE BALANCE | DQX | Substantially Equivalent | |
| K152404 | Hi-Torque Command 18 Guide Wire | DQX | Substantially Equivalent | |
| K151317 | Armada 18 PTA Catheter | LIT | Substantially Equivalent | |
| K142415 | Hi-Torque JET Guide Wire Family | DQX | Substantially Equivalent | |
| K141782 | HI-TORQUE VERSATURN GUIDE WIRE | DQX | Substantially Equivalent | |
| K141678 | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM | NTE | Substantially Equivalent | |
| K123279 | MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN | LOX | Substantially Equivalent | |
| K123067 | PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY | DQX | Substantially Equivalent | |
| K122573 | HI-TORQUE COMMAND GUIDE WIRE FAMILY | DQX | Substantially Equivalent | |
| K121352 | ARMADA 14XXT PTA CATHETER | DQY | Substantially Equivalent | |
| K121222 | TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER | LOX | Substantially Equivalent | |
| K121015 | EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM | NTE | Substantially Equivalent | |
| K113464 | NC TREK OTW CORONARY DILATATION CATHETER | LOX | Substantially Equivalent | |
| K111899 | ARMADA 35/35LL PTA CATHETER | LIT | Substantially Equivalent | |
| K112239 | STEERABLE GUIDE CATHETER | DRA | Substantially Equivalent | |
| K110617 | MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER | LOX | Substantially Equivalent | |
| K102705 | ARMADA 14 PTA CATHETER | LIT | Substantially Equivalent | |
| K101648 | HI-TORQUE WINN GUIDE WIRE FAMILY | DQX | Substantially Equivalent | |
| K101011 | HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL | DQX | Substantially Equivalent | |
| K091825 | HI-TORQUE PROGRESS GUIDE WIRE FAMILY | DQX | Substantially Equivalent | |
| K092286 | FOX SV PTA CATHETER | LIT | Substantially Equivalent | |
| K083738 | HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05 | DQX | Substantially Equivalent | |
| K083732 | TAD AND TAD II TAPERED GUIDE WIRES | DQX | Substantially Equivalent | |
| K083713 | .035 LOC GUIDE WIRE EXTENSION | DQX | Substantially Equivalent | |
| K083706 | HI-TORQUE VERSACORE GUIDE WIRE | DQX | Substantially Equivalent | |
| K081417 | FOXCROSS PTA CATHETER | LIT | Substantially Equivalent | |
| K080925 | FOX PLUS PTA CATHETER | LIT | Substantially Equivalent | |
| K072460 | HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE | DQX | Substantially Equivalent | |
| K063481 | MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM | FGE | Unknown | |
| K062554 | STARCLOSE HEX-HUB DILATOR | DRE | Substantially Equivalent | |
| K060902 | STARCLOSE INTRODUCER SET MODEL- 1002 | DYB | Substantially Equivalent | |
| K060817 | OMNILINK. 018 BILIARY STENT SYSTEM | FGE | Unknown | |
| K052454 | THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM | NTE | Substantially Equivalent | |
| K050501 | MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM | FGE | Unknown | |
| K032929 | MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822 | FGE | Unknown | |
| K031331 | WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM | FGE | Unknown | |
| K021062 | CHITO-SEAL | QSY | Substantially Equivalent | |
| K014118 | MODIFICATION TO SUPERCROSS CATHETER | DQY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2024168 | 2024168 | ABBOTT VASCULAR | 26531 YNEZ RD., Temecula, CA 92591 US | 2026 | and 22 more, listed in full below |
| 2939561 | 3004635528 | ABBOTT VASCULAR | 3200 Lakeside Dr, SANTA CLARA, CA 95054 US | 2026 | and 14 more, listed in full below |
| 3005718570 | 3005718570 | ABBOTT VASCULAR | CASHEL ROAD, CLONMEL Tipperary , IE | 2026 | |
| 3005737652 | 3005737652 | ABBOTT VASCULAR | Building PR-17, Road #2, km 58.0, Cruce Davila, Barceloneta, PR 00617 US | 2026 | |
| 3005070406 | 3005070406 | Abbott Vascular | 3885 Bohannon Drive, Menlo Park, CA 94025 US | 2026 | |
| 3009564766 | 3009564766 | Abbott Vascular | 52 Calle 3, El Coyol Alajuela 20102 CR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PNYAbsorbable Coronary Drug-Eluting Stent
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- QEZAspiration Thrombectomy Catheter
- KDQBottle, Collection, Vacuum
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- QWACardiovascular Delivery Catheter System Positioning And Stabilization Device
- LITCatheter, Angioplasty, Peripheral, Transluminal
- MCXCatheter, Coronary, Atherectomy
- DYGCatheter, Flow Directed
- DQOCatheter, Intravascular, Diagnostic
- DQYCatheter, Percutaneous
- DRACatheter, Steerable
- LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous
- DSKComputer, Blood-Pressure
- DQKComputer, Diagnostic, Programmable
- NIVCoronary Covered Stent
- NIQCoronary Drug-Eluting Stent
- MGBDevice, Hemostasis, Vascular
- DREDilator, Vessel, For Percutaneous Catheterization
- LDFElectrode, Pacemaker, Temporary
- QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics
- DYBIntroducer, Catheter
- OUGMedical Device Data System
- NKMMitral Valve Repair Devices
- NXWScaffold, Infrapopliteal, Absorbable
- FOXStand, Infusion
- NIMStent, Carotid
- MAFStent, Coronary
- NIOStent, Iliac
- NINStent, Renal
- NIPStent, Superficial Femoral Artery
- FGEStents, Drains And Dilators For The Biliary Ducts
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene
- MAVSyringe, Balloon Inflation
- NQQSystem, Imaging, Optical Coherence Tomography (Oct)
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- NTETemporary Carotid Catheter For Embolic Capture
- DXOTransducer, Pressure, Catheter Tip
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
- NPSTricuspid Valve Repair Device, Percutaneously Delivered
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 78| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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. | Class II | Open, Classified | |
| 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. | Class II | Open, Classified | |
| Z-0731-2025 | 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices). | 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. | Class II | Open, Classified | |
| Z-0730-2025 | 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon. | 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. | Class II | Open, Classified | |
| Z-0117-2023 | Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR Clinical/CDS0704-NTW, MitraClip G4 CDS XT REPAIR-MR Clinical/CDS0704-XT, MitraClip G4 CDS XTW REPAIR-MR Clinical/CDS0704-XTW, TriClip NT Clip Delivery Sys CLIN/TCDS0203-NT, TriClip XT Clip Delivery Sys CLIN/TCDS0203-XT, TriClip G4 NT Delivery System CLIN/TCDS0303-NT, TriClip G4 NTW Delivery System CLIN/TCDS0303-NTW, TriClip G4 XT Delivery System CLIN/TCDS0303-XT, TriClip G4 XTW Delivery System CLIN/TCDS0303-XTW, TriClip NT Clip Delivery Sys CLIN/TCDS0203-NT, TriClip XT Clip Delivery Sys CLIN/TCDS0203-XT. For cardiac procedures. | An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury. | Class II | Open, Classified | |
| Z-0116-2023 | Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System CE/CDS0602-NTR, MitraClip XTR Clip Delivery System CE/CDS0602-XTR, MitraClip G4 Clip Delivery System NT CE/CDS0702-NT, MitraClip G4 Clip Delivery System NTW CE/CDS0702-NTW, MitraClip G4 Clip Delivery System XT CE/CDS0702-XT, MitraClip G4 Clip Delivery System XTW CE/CDS0702-XTW, MitraClip G4 Clip Delivery Sys NT ROW/CDS0705-NT, MitraClip G4 Clip Delivery Sys NTW ROW/CDS0705-NTW, MitraClip G4 Clip Delivery Sys XT ROW/CDS0705-XT, MitraClip G4 Clip Delivery Sys XTW ROW/CDS0705-XTW, TriClip XT Clip Delivery Sys CE/TCDS0202-XT, TriClip NT Clip Delivery Sys CE/TCDS0202-NT, TriClip XT Clip Delivery Sys ROW/TCDS0205-XT, TriClip NT Clip Delivery Sys ROW/TCDS0205-NT, TriClip G4 NT Delivery System CE/TCDS0302-NT, TriClip G4 NTW Delivery System CE/TCDS0302-NTW, TriClip G4 XT Delivery System CE/TCDS0302-XT, TriClip G4 XTW Delivery System CE/TCDS0302-XTW, TriClip G4 NT Delivery System ROW/TCDS0305-NT, TriClip G4 NTW Delivery System ROW/TCDS0305-NTW, TriClip G4 XT Delivery System ROW/TCDS0305-XT, TriClip G4 XTW Delivery System ROW/TCDS0305-XTW, TriClip NT Clip Delivery Sys CE/TCDS0202-NT, TriClip NT Clip Delivery Sys ROW/TCDS0205-NT. For cardiac procedures. | An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury. | Class II | Open, Classified | |
| Z-0115-2023 | Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, MitraClip G4 Clip Delivery System NTW US/CDS0701-NTW, MitraClip G4 Clip Delivery System XT US/CDS0701-XT, MitraClip G4 Clip Delivery System XTW US/CDS0701-XTW. For cardiac procedures. | An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury. | Class II | Open, Classified | |
| 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 | Class I | Open, Classified | |
| 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 1000185-115 WPL2122279-01 (2019-03-01) | Due to an increase in complaint trend for leaks and intermittent/loose connections. | Class II | Open, Classified | |
| 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. | Class II | Open, Classified | |
| 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. | Class II | Open, Classified | |
| 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 - REF 1000186-115 WPL2122270-02 (2019-03-01) | Due to an increase in complaint trend for leaks and intermittent/loose connections. | Class II | Open, Classified | |
| 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. | Class II | Open, Classified | |
| Z-2370-2020 | Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 g/cm, Nominal Everolimus Content: 209 g; Lot number 903224A, | Incorrect expiration date | Class II | 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 Coronary Dilatation Catheter is not cleared for commercial distribution in the United States. | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 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 Coronary Dilatation Catheter is not cleared for commercial distribution in the United States. | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 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 Coronary Dilatation Catheter is not cleared for commercial distribution in the United States. | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 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 Coronary Dilatation Catheter is not cleared for commercial distribution in the United States. | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 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 Coronary Dilatation Catheter is not cleared for commercial distribution in the United States. | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 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 Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 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 Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 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 Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 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 Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 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 Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | 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 Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only) | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | Class I | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain