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 |
|---|---|---|---|
| Feb 10, 2004 | K033622 | POLARCATH PERIPHERAL DILATATION SYSTEM Cryo Vascular Systems, Inc. | DQY |
| Jan 22, 2004 | K033989 | MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69 Medtronic Inc. Cardiac Rhythm Management | DQY |
| Nov 21, 2003 | K033441 | BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER Boston Scientific Corp | DQY |
| Nov 19, 2003 | K033320 | SCOUT PRO Biotronik, Inc. | DQY |
| Nov 19, 2003 | K032869 | COOK CODA BALLOON CATHETER Cook, Inc. | DQY |
| Nov 18, 2003 | K032784 | ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 Intra Luminal Therapeutics, Inc. | DQY |
| Oct 31, 2003 | K033217 | PHERON PTA CATHETER Biotronik, Inc. | DQY |
| Oct 29, 2003 | K032660 | XTRAK SUPPORT CATHETER Xtrak Medical, Inc. | DQY |
| Oct 22, 2003 | K032931 | PTA BALLOON CATHETER Cook, Inc. | DQY |
| Oct 21, 2003 | K032312 | ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM Medtronic Vascular | DQY |
| Oct 2, 2003 | K032737 | CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA Cordis Europa, N.V. | DQY |
| Oct 2, 2003 | K032587 | EDWARDS PERIPHERAL DILATATION CATHETER Edwards Lifesciences, LLC | DQY |
| Sep 25, 2003 | K032591 | NUMED TYSHAK MINI PEDIATRIC PTV CATHETER NuMED, Inc. | DQY |
| Sep 3, 2003 | K032622 | ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS Medtronic Vascular | DQY |
| Sep 3, 2003 | K030630 | EDWARDS DIRECTIONAL CATHETER Edwards Lifesciences, LLC | DQY |
| Aug 27, 2003 | K032069 | WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER AngioDynamics, Inc. | DQY |
| Aug 26, 2003 | K032298 | MODIFICATION TO OUTBACK CATHETER Lumend, Inc. | DQY |
| Aug 22, 2003 | K031692 | SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 Intra Luminal Therapeutics, Inc. | DQY |
| Aug 4, 2003 | K023548 | PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101 Velocimed | DQY |
| Jul 31, 2003 | K030671 | MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB Medtronic Vascular | DQY |
| Jul 23, 2003 | K031459 | RAPIDO CUT-AWAY CUTTER Guidant Corp. | DQY |
| Jul 17, 2003 | K031211 | ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH Medtronic Vascular | DQY |
| Jul 11, 2003 | K031417 | ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1 Intra Luminal Therapeutics, Inc. | DQY |
| Jun 26, 2003 | K031766 | ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER Cook, Inc. | DQY |
| Jun 25, 2003 | K031505 | RAPIDO CUT-AWAY GUIDING CATHETER Guidant Corporation | DQY |
| May 21, 2003 | K030589 | MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS NuMED, Inc. | DQY |
| Apr 24, 2003 | K030984 | SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT Intra Luminal Therapeutics, Inc. | DQY |
| Apr 24, 2003 | K030779 | 5F MEDTRONIC LAUNCHER GUIDE CATHETER Medtronic Vascular | DQY |
| Apr 24, 2003 | K030715 | SAFFRON NM GUIDING CATHETER Neich Medical (Shenzhen) Company Limited, CN | DQY |
| Apr 8, 2003 | K021802 | STEREOTAXIS CATHETER ADVANCER SYSTEM Stereotaxis, Inc. | DQY |
| Mar 25, 2003 | K024327 | SETPOINT ENDOVASCULAR TEMPERATURE PROBE Radiant Medical | DQY |
| Mar 11, 2003 | K030476 | MODIFIED CONCENTRIC RETRIEVER, MODEL 90037 Concentric Medical, Inc. | DQY |
| Feb 19, 2003 | K023463 | CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNIT Cryo Vascular Systems, Inc. | DQY |
| Dec 30, 2002 | K024035 | ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY Medtronic Vascular | DQY |
| Dec 30, 2002 | K024032 | ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY Medtronic Vascular | DQY |
| Dec 10, 2002 | K023320 | AGILTRAC .035 PERIPHERAL DILATATION CATHETER Guidant Corp. | DQY |
| Nov 6, 2002 | K023402 | 8F LAUNCHER GUIDE CATHETER Medtronic Vascular | DQY |
| Oct 24, 2002 | K023223 | MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER Lumend, Inc. | DQY |
| Sep 27, 2002 | K022552 | ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER Cook, Inc. | DQY |
| Sep 23, 2002 | K022138 | SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028 Spectranetics Corp. | DQY |
| Sep 20, 2002 | K022061 | CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER Cryo Vascular Systems, Inc. | DQY |
| Sep 13, 2002 | K022738 | AGILTRAC .035 PERIPHERAL DILATATION CATHETER Guidant Corp. | DQY |
| Sep 13, 2002 | K022722 | PTA AND PTV NuMED, Inc. | DQY |
| Aug 28, 2002 | K022764 | 7F LAUNCHER GUIDE CATHETER Medtronic Vascular | DQY |
| Aug 8, 2002 | K021735 | BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER Boston Scientific Scimed, Inc. | DQY |
| Aug 2, 2002 | K021455 | RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782, Guidant Corp. | DQY |
| Jul 10, 2002 | K021899 | CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072 Concentric Medical, Inc. | DQY |
| Jun 20, 2002 | K021721 | EQUALIZER BALLOON CATHETER Boston Scientific Corp | DQY |
| Jun 13, 2002 | K021593 | MODIFICATION TO ENVOY AND VISTA BRITE TIP Cordis Corp. | DQY |
| May 30, 2002 | K021589 | ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218 Medtronic Vascular | DQY |
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