Panels › Cardiovascular › Product code DQY · Class 2
Catheter, Percutaneous
Regulation 870.1250
13510(k)s in 12 months (896 all time)
2recalls in 12 months (620 all time)
583recalls that name a 510(k)
Top companies in DQY
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Vascular | 31 | 198 |
| Medtronic | 15 | 148 |
| Boston Scientific | 30 | 59 |
| ARROW INTERNATIONAL, LLC | 0 | 41 |
| Stryker Neurovascular | 6 | 30 |
| Cook Incorporated | 22 | 13 |
| Vascular Solutions, Inc. | 27 | 6 |
| Codman & Shurtleff, Inc. | 8 | 24 |
| Bard Peripheral Vascular, Inc. | 5 | 23 |
| Cordis Corp. | 22 | 4 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 30, 2002 | K021587 | ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A Medtronic Vascular | DQY |
| May 17, 2002 | K021256 | Z3 GUIDE CATHETER Medtronic Vascular | DQY |
| May 2, 2002 | K021284 | EASYTRAK GUIDING CATHETER Guidant Corp. | DQY |
| May 2, 2002 | K021120 | RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP Arrow Intl., Inc. | DQY |
| May 2, 2002 | K021088 | JOGUIDE CARDIOVASCULAR GUIDING C ATHETER Jomed Catheter, Inc. | DQY |
| Apr 25, 2002 | K013517 | 10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600 Medtronic Vascular | DQY |
| Feb 28, 2002 | K013963 | MODEL 9210 DELIVERY CATHETER, MODEL 9210 Medtronic Vascular | DQY |
| Feb 22, 2002 | K020161 | AGILTRAC .018 PERIPHERAL DILATATION CATHETER Guidant Corp. | DQY |
| Feb 11, 2002 | K013284 | LUMEND FRONTRUNNER CTO CORONARY CATHETER Lumend, Inc. | DQY |
| Jan 22, 2002 | K020028 | 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX Boston Scientific | DQY |
| Jan 17, 2002 | K014212 | BARD CONQUEST PTA BALLOON DILATATION CATHETER C.R. Bard, Inc. | DQY |
| Jan 16, 2002 | K011562 | LUMEND PERCUTANEOUS CATHETER Lumend, Inc. | DQY |
| Jan 11, 2002 | K014118 | MODIFICATION TO SUPERCROSS CATHETER Abbott Vascular, Inc. | DQY |
| Jan 11, 2002 | K014117 | MODIFICATION TO OUTBACK CATHETER Lumend, Inc. | DQY |
| Jan 3, 2002 | K013601 | NUMED MULLINS PTA CATHETER NuMED, Inc. | DQY |
| Dec 21, 2001 | K011889 | ULTRA -THIN SDS BALLOON DILATATION CATHETER Boston Scientific Corp | DQY |
| Dec 6, 2001 | K013789 | EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 Boston Scientific, Target | DQY |
| Dec 4, 2001 | K013638 | MODIFICATION TO VIKING OPTIMA GUIDING CATHETER Guidant Corp. | DQY |
| Nov 28, 2001 | K013581 | CORDIS AVIATOR PERIPHERAL DILATATION CATHETER Cordis, A Johnson & Johnson Co. | DQY |
| Nov 21, 2001 | K010579 | STENT SUPPORT GUIDE CATHETER Medtronic Vascular | DQY |
| Oct 9, 2001 | K010954 | CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031 Concentric Medical, Inc. | DQY |
| Sep 28, 2001 | K012913 | BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER C.R. Bard, Inc. | DQY |
| Sep 6, 2001 | K012050 | VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER Guidant Corp. | DQY |
| Aug 30, 2001 | K012169 | ILT SUPPORT CATHETER .014, MODEL C114LW1; ILT SUPPORT CATHETER ADVANCING MECHANISM, MODEL A11AM1 Intra Luminal Therapeutics, Inc. | DQY |
| Aug 28, 2001 | K012130 | ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM Medtronic Vascular | DQY |
| Aug 28, 2001 | K012083 | ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218 Medtronic Vascular | DQY |
| Jul 26, 2001 | K012002 | VIKING OPTIMA GUIDING CATHETER Guidant Corp. | DQY |
| Jun 21, 2001 | K010874 | 6F MACH 1, MODEL 34356-XXX Boston Scientific Corp | DQY |
| Jun 21, 2001 | K010838 | FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A14004, A14005, A14006, A14007, A14008 Jomed AG | DQY |
| Jun 15, 2001 | K003920 | CORDIS M3 PTA DILATATION CATHETER Cordis Corp. | DQY |
| Jun 13, 2001 | K011464 | RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER, RX HERCULINK 14 BILIARY STN Vascular Intervention | DQY |
| Jun 13, 2001 | K010831 | AVIATOR PERIPHERAL DILATATION CATHETER Guidant Corp. | DQY |
| May 22, 2001 | K003410 | CONCENTRIC RETRIEVER, MODEL 90030 Concentric Medical, Inc. | DQY |
| May 16, 2001 | K003880 | CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F) Concentric Medical, Inc. | DQY |
| May 15, 2001 | K001694 | GUIDANT RETRIEVER DEVICE Guidant Cardiac and Vascular Surgery | DQY |
| Apr 20, 2001 | K010880 | NUMED HIGH PRESSURE PTA CATHETERS NuMED, Inc. | DQY |
| Apr 18, 2001 | K010853 | GUIDER SOFTIP GUIDING CATHETER XF 5F Boston Scientific, Target | DQY |
| Apr 18, 2001 | K010531 | ILT DEFLECTING CATHETER, MODEL C114ND1 Intra Luminal Therapeutics, Inc. | DQY |
| Mar 7, 2001 | K003085 | CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020 Concentric Medical, Inc. | DQY |
| Mar 7, 2001 | K001856 | SUPERCROSS CATHETER Abbott Vascular, Inc. | DQY |
| Feb 13, 2001 | K010169 | BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER C.R. Bard, Inc. | DQY |
| Feb 7, 2001 | K003495 | ANCURE LLIAC BALLOON CATHETER Guidant Cardiac and Vascular Surgery | DQY |
| Jan 11, 2001 | K001577 | OUTBACK CATHETER Lumend, Inc. | DQY |
| Dec 27, 2000 | K003643 | NUMED Z-MED PTV CATHERERS NuMED, Inc. | DQY |
| Sep 25, 2000 | K001992 | ILT 0.014 CATHETER, MODEL C114NL2 Intra Luminal Therapeutics, Inc. | DQY |
| Aug 16, 2000 | K001969 | GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300 Medtronic Vascular | DQY |
| Jun 2, 2000 | K001435 | VIKING OPTIMA GUIDING CATHETER Guidant Corp. | DQY |
| Apr 28, 2000 | K001136 | CORDIS INTRODUCER GUIDE Cordis Corp. | DQY |
| Mar 31, 2000 | K000715 | ENVOY AND VISTA BRITE TIP Cordis Corp. | DQY |
| Mar 29, 2000 | K000677 | ZUMA GUIDE CATHETERS Medtronic Vascular | DQY |
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