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 |
|---|---|---|---|
| Aug 5, 2011 | K110813 | HEADWAY 27 MICROCATHETER MicroVention, Inc. | DQY |
| Aug 1, 2011 | K111334 | BENELLI ACCESS DEVICE Vascular Solutions, Inc. | DQY |
| Jul 29, 2011 | K111556 | GLIDECROSS SUPPORT CATHETER Terumo Medical Corp. | DQY |
| Jul 21, 2011 | K111750 | EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE Angioslide, Ltd. | DQY |
| Jul 19, 2011 | K111380 | NEURON MAX SYSTEM Penumbra, Inc. | DQY |
| Jul 13, 2011 | K111850 | VACCESS PTA DILATATION CATHETER C.R. Bard, Inc. | DQY |
| Jun 2, 2011 | K111252 | ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F Boston Scientific Corp | DQY |
| May 23, 2011 | K111154 | SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75 Biotronik, Inc. | DQY |
| May 13, 2011 | K110540 | TERUMO SUPPORT CATHETER Terumo Medical Corp. | DQY |
| May 10, 2011 | K102725 | CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M Bridge Medical, Inc. | DQY |
| Apr 20, 2011 | K110461 | SELECTRA CS LEAD INTRODUCER SYSTEM Biotronik, Inc. | DQY |
| Apr 15, 2011 | K102418 | REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM Reverse Medical Corporation | DQY |
| Apr 5, 2011 | K110055 | REVERSE MEDICAL REFLEX GUIDE CATHETER Reverse Medical Corporation | DQY |
| Apr 4, 2011 | K110483 | MODIFIED HD GUIDE CATHETER Concentric Medical, Inc. | DQY |
| Feb 14, 2011 | K100184 | FUSTAR STEERABLE INTRODUCERS Lifetech Scientific (Shenzhen) Co., Ltd., CN | DQY |
| Feb 11, 2011 | K103386 | MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS Medtronic, Inc. | DQY |
| Jan 19, 2011 | K103250 | CPS DIRECT SL II SLITTABLE OUTER CATHETER St. Jude Medical, Cardiac Rhythm Management Divisi | DQY |
| Jan 18, 2011 | K102979 | NEXGEN PERIPHERAL GUIDE CATHETER Nexgen Medical Systems, Inc. | DQY |
| Jan 5, 2011 | K103534 | GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE Trireme Medical, Inc. | DQY |
| Dec 16, 2010 | K101659 | SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301 Vascular Solutions, Inc. | DQY |
| Dec 8, 2010 | K103367 | SEEKER CROSSING SUPPORT CATHETER Bard Peripheral Vascular, Inc. | DQY |
| Nov 17, 2010 | K102657 | CONCENTRIC BALLOON GUIDE CATHETER Concentric Medical, Inc. | DQY |
| Sep 23, 2010 | K101015 | GUIDE CATHETERS AND ACCESSORIES Thomas Medical Products, Inc. | DQY |
| Sep 9, 2010 | K101885 | MEDTRONIC C315 DELIVERY CATHETER Medtronic, Inc. | DQY |
| Aug 11, 2010 | K101479 | WINGMAN EXTENDABLE TIP SUPPORT CATHETER Reflow Medical | DQY |
| Aug 6, 2010 | K102022 | WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S Avinger, Inc. | DQY |
| Aug 6, 2010 | K101877 | OCCLUSION BALLOON CATHETER MODEL OBC Cook, Inc. | DQY |
| Aug 6, 2010 | K101647 | WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500 Avinger, Inc. | DQY |
| Aug 6, 2010 | K101591 | STINGRAY ORIENTING BALLOON CATHETER Bridgepoint Medical | DQY |
| Aug 6, 2010 | K101542 | HEADWAY 17 ADVANCED MICROCATHETER MicroVention, Inc. | DQY |
| Jul 23, 2010 | K101776 | SCOUTPRO ACS Biotronik, Inc. | DQY |
| Jul 21, 2010 | K101282 | SCOUTPRO HEMOSTATIC VALVE Biotronik, Inc. | DQY |
| Jul 16, 2010 | K101117 | LEV-OR DILATION CATHETER OTW Baylis Medical Co., Inc., CA | DQY |
| Jul 13, 2010 | K100826 | PENUMBRA CATHERER 025 Penumbra, Inc. | DQY |
| Apr 22, 2010 | K093977 | ALLIGATOR-HD RETRIEVAL DEVICE (ARD-HD), MODEL FA-88840-XX Chestnut Medical Technologies, Inc. | DQY |
| Apr 20, 2010 | K093431 | CLEARWAY OTW MODEL 85912 Atrium Medical Corp. | DQY |
| Apr 16, 2010 | K100135 | GDS-DC12 Guided Delivery Systems | DQY |
| Mar 5, 2010 | K093969 | ACUITY BREAK-AWAY GUIDE CATHETER Cardiac Pacemakers, Inc. | DQY |
| Feb 26, 2010 | K091188 | ASAHI ZENYTEEX GUIDING CATHETER Asahi Intecc Co., Ltd. | DQY |
| Feb 12, 2010 | K094019 | GLIDER PTA BALLOON CATHETER Trireme Medical, Inc. | DQY |
| Feb 5, 2010 | K093476 | AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120 Aga Medical Corp. | DQY |
| Dec 30, 2009 | K092174 | ENABLER-P CATHETER SYSTEM, MODEL 3000 Endocross, Ltd. | DQY |
| Dec 18, 2009 | K093050 | ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 Arrow Intl., Inc. | DQY |
| Nov 20, 2009 | K093303 | SCOUTPRO 7F LONG CATHETERS Biotronik, Inc. | DQY |
| Nov 6, 2009 | K093184 | ENVOY GUIDING CATHETERS Codman & Shurtleff, Inc. | DQY |
| Nov 5, 2009 | K093160 | HEADWAY 21 MICROCATHETER, MODEL: MC212150S MicroVention, Inc. | DQY |
| Nov 5, 2009 | K092298 | MODIFICATION TO MODIFIED HD GUIDE CATHETER Concentric Medical, Inc. | DQY |
| Nov 4, 2009 | K091750 | GUIDELINER CATHETER, MODELS 5571, 5572, 5573 Vascular Solutions, Inc. | DQY |
| Oct 15, 2009 | K091624 | STENT GRAFT BALLOON CATHETER Via Biomedical, Inc. | DQY |
| Sep 4, 2009 | K092396 | SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS Spectranetics Corp. | DQY |
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