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 |
|---|---|---|---|
| Sep 2, 2009 | K091841 | BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 Bridgepoint Medical | DQY |
| Aug 7, 2009 | K092299 | TRAILBLAZER SUPPORT CATHETER Ev3, Inc. | DQY |
| Aug 7, 2009 | K092075 | CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005 St. Jude Medical, Cardiac Rhythm Management Divisi | DQY |
| Jul 30, 2009 | K090918 | NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER Nfocus Neuromedical, Inc. | DQY |
| Jul 9, 2009 | K091793 | AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54 Aga Medical Corp. | DQY |
| Jul 1, 2009 | K091299 | SPECTRANETICS TURBO-TANDEM SYSTEM Spectranetics Corp. | DQY |
| Jul 1, 2009 | K090613 | CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 St. Jude Medical, Cardiac Rhythm Management Divisi | DQY |
| Jun 18, 2009 | K090977 | PIGGYBACK WIRE CONVERTER Vascular Solutions, Inc. | DQY |
| Jun 12, 2009 | K091527 | ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER Cook, Inc. | DQY |
| Jun 12, 2009 | K091345 | GOPHER GOLD CATHETER, MODEL 5620 Vascular Solutions, Inc. | DQY |
| May 29, 2009 | K091254 | THE CROSSER 14 OTW CATHETER, MODEL CRU014 Flowcardia, Inc. | DQY |
| May 22, 2009 | K083833 | ENABLER-P CATHETER, 1000 PART NUMBER:1160 Endocross, Ltd. | DQY |
| May 14, 2009 | K081130 | BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER Bridgepoint Medical | DQY |
| May 12, 2009 | K083214 | AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100 Aga Medical Corp. | DQY |
| May 6, 2009 | K090335 | HD GUIDE CATHETER Concentric Medical, Inc. | DQY |
| May 4, 2009 | K090913 | CROSS-PILOT TURBO ELITE SUPPORT CATHETER Spectranetics Corp. | DQY |
| May 1, 2009 | K090849 | MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150 Ev3, Inc. | DQY |
| Apr 27, 2009 | K090822 | ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER Cook, Inc. | DQY |
| Mar 26, 2009 | K090659 | ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERY Medtronic, Inc. | DQY |
| Mar 20, 2009 | K090509 | FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER Abbott Vascular-Vascular Solutions | DQY |
| Mar 13, 2009 | K083919 | AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER Invatec Innovative Technologies, S.R.L. | DQY |
| Mar 2, 2009 | K083596 | REEKROSS FAMILY OR OTW PTA CATHETERS ClearStream Technologies , Ltd., IE | DQY |
| Feb 6, 2009 | K083422 | 6F TAIGA GUIDING CATHETER Medtronic Vascular | DQY |
| Feb 6, 2009 | K080987 | BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES Bridgepoint Medical | DQY |
| Feb 3, 2009 | K083127 | ASAHI CORSAIR MICROCATHETER Asahi Intecc Co., Ltd. | DQY |
| Feb 2, 2009 | K083313 | WILDCAT 7F GUIDEWIRE SUPPORT CATHETER Avinger, Inc. | DQY |
| Jan 27, 2009 | K081878 | LEMAITRE TT TORTUOUS TRACKER INTRODUCER CATHETER DELIVERY SYSTEM LeMaitre Vascular, Inc. | DQY |
| Jan 15, 2009 | K082337 | MINNIE SUPPORT CATHETER Vascular Solutions, Inc. | DQY |
| Dec 24, 2008 | K083657 | CONQUEST PTA BALLOON DILATATION CATHETER C.R. Bard, Inc. | DQY |
| Dec 12, 2008 | K082932 | CPS AIM SL SLITTABLE INNER CATHETER St Jude Medical | DQY |
| Dec 11, 2008 | K082559 | SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER Spectranetics Corp. | DQY |
| Dec 11, 2008 | K082385 | CHAPERON GUIDING CATHETER MicroVention, Inc. | DQY |
| Dec 10, 2008 | K082561 | SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS Spectranetics Corp. | DQY |
| Dec 9, 2008 | K080428 | ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY Medtronic, Inc. | DQY |
| Dec 4, 2008 | K083343 | HEADWAY 17 MICROCATHETER MicroVention, Inc. | DQY |
| Dec 4, 2008 | K082854 | NANOCORSS .014 OTW PTA DILATATION CATHETER Ev3, Inc. | DQY |
| Dec 4, 2008 | K082670 | MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET Medtronic, Inc. | DQY |
| Nov 25, 2008 | K083139 | VIPERSPHERE PTA BALLOON CATHETER Cardiovascular Systems, Inc. | DQY |
| Nov 21, 2008 | K083125 | NEURON SELECT CATHETER SIZE 070 Penumbra, Inc. | DQY |
| Nov 20, 2008 | K082579 | EVERCROSS .035 OTW PTA DILATATION CATHETER Ev3, Inc. | DQY |
| Nov 20, 2008 | K082339 | ENABLER-P SUPPORT CATHETER Endocross, Ltd. | DQY |
| Nov 3, 2008 | K082933 | PASSEO-35 PTA CATHETER Biotronik, Inc. | DQY |
| Nov 3, 2008 | K082646 | OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER Usci Ireland | DQY |
| Oct 31, 2008 | K082290 | NEURON DELIVERY CATHETER 070 Penumbra, Inc. | DQY |
| Oct 24, 2008 | K082868 | MULLINS-X, MODEL 250X NuMED, Inc. | DQY |
| Oct 3, 2008 | K081799 | GORE TRI-LOBE BALLOON CATHETER W. L. Gore & Associates, Inc. | DQY |
| Oct 2, 2008 | K073700 | 6F PROXIS SYSTEM St. Jude Medical, Inc. | DQY |
| Sep 26, 2008 | K082524 | MINI GHOST, MODEL: 507 NuMED, Inc. | DQY |
| Jul 25, 2008 | K080849 | MICROSHEATH LP AND LP-AT Flowcardia, Inc. | DQY |
| Jul 18, 2008 | K080583 | MODIFIED HD GUIDE CATHETER Concentric Medical, Inc. | DQY |
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