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 |
|---|---|---|---|
| Jul 10, 2008 | K081680 | NUCLEUS-X, MODEL 230X NuMED, Inc. | DQY |
| May 16, 2008 | K080994 | AMPLATZER TORQVUE EXCHANGE SYSTEM Aga Medical Corp. | DQY |
| May 7, 2008 | K080988 | SCOUTPRO CS LEAD INTRODUCER SYSTEM Biotronik, Inc. | DQY |
| Apr 18, 2008 | K080757 | AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM Aga Medical Corp. | DQY |
| Apr 8, 2008 | K080360 | ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER Endologix, Inc. | DQY |
| Mar 25, 2008 | K072329 | SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED Biotronik, Inc. | DQY |
| Mar 20, 2008 | K080154 | ACUITY UNIVERSAL CUTTER Cardiac Pacemakers, Inc. | DQY |
| Feb 8, 2008 | K070126 | OCCLUSION BALLOON CATHETER Sentreheart, Inc. | DQY |
| Jan 11, 2008 | K073289 | MICROSHEATH XL CATHETERS Flowcardia, Inc. | DQY |
| Dec 28, 2007 | K073378 | ADVANCE 18LP PTA DILATATION CATHETER Cook, Inc. | DQY |
| Dec 4, 2007 | K072750 | SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066 Spectranetics Corp. | DQY |
| Nov 21, 2007 | K072618 | TWIN-PASS OTW CATHETER, MODEL 5201 Vascular Solutions, Inc. | DQY |
| Nov 9, 2007 | K072156 | OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER Usci Ireland | DQY |
| Nov 2, 2007 | K072313 | AMPLATZER TORQVUE DELIVERY SYSTEM Aga Medical Corp. | DQY |
| Oct 4, 2007 | K070502 | RADIUS SNARE Radius Medical Technologies, Inc. | DQY |
| Sep 19, 2007 | K072283 | DORADO PTA BALLOON DILATATION CATHETER Bard Peripheral Vascular, Inc. | DQY |
| Sep 17, 2007 | K072316 | PRECIOUS PLUS GUIDE CATHETER Asahi Intecc Co., Ltd. | DQY |
| Aug 17, 2007 | K070970 | NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F Penumbra, Inc. | DQY |
| Jul 18, 2007 | K071665 | SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552 Biotronik, Inc. | DQY |
| Jun 13, 2007 | K062885 | STRIDE MICROCATHETER Asahi Intecc Co., Ltd. | DQY |
| Jun 1, 2007 | K070372 | GOPHER 2F SUPPORT CATHETER, MODEL 5600 AND GOPHER 3F SUPPORT CATHETER, MODEL 5610 Vascular Solutions, Inc. | DQY |
| May 11, 2007 | K063638 | MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101 St Jude Medical | DQY |
| Apr 6, 2007 | K070051 | ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM Acumen Medical, Inc. | DQY |
| Feb 28, 2007 | K070238 | AMPLATZER RELIANT CATHETER DELIVERY SYSTEM Aga Medical Corp. | DQY |
| Jan 19, 2007 | K062868 | THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02 Flowcardia, Inc. | DQY |
| Dec 15, 2006 | K061680 | ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER Atrium Medical Corp. | DQY |
| Nov 17, 2006 | K061601 | ASAHI PRECIOUS GUIDE CATHETER Asahi Intecc Co., Ltd. | DQY |
| Nov 14, 2006 | K063252 | ATB ADVANCED PTA DILATATION CATHETER Cook, Inc. | DQY |
| Oct 25, 2006 | K061416 | SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74 Medtronic Vascular | DQY |
| Oct 20, 2006 | K062202 | OCCLUSION BALLOON Boston Scientific Corp | DQY |
| Oct 18, 2006 | K062809 | ADMIRAL XTREME PTA CATHETER Invatec Innovative Technologies | DQY |
| Oct 6, 2006 | K062609 | MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER AngioDynamics, Inc. | DQY |
| Oct 6, 2006 | K060927 | CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES Ceres Medical Systems, LLC | DQY |
| Sep 20, 2006 | K062594 | MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM Boston Scientific Corporation | DQY |
| Sep 8, 2006 | K062420 | 5F SHERPA ACTIVE NX GUIDE CATHETER Medtronic Vascular | DQY |
| Aug 21, 2006 | K061480 | ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM Medtronic, Ireland | DQY |
| Aug 18, 2006 | K062084 | 7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67 Acumen Medical, Inc. | DQY |
| Aug 9, 2006 | K042850 | CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE) Stereotaxis, Inc. | DQY |
| Aug 1, 2006 | K061843 | VENTURE WIRE CONTROL CATHETER, MODEL WCC St Jude Medical | DQY |
| Jul 14, 2006 | K061710 | CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLS St Jude Medical | DQY |
| Jun 23, 2006 | K060745 | ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY Asahi Intecc Co., Ltd. | DQY |
| May 18, 2006 | K061119 | ENPATH MEDICAL STEERABLE SHEATH Enpath Medical, Inc. | DQY |
| Apr 27, 2006 | K053491 | PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F Penumbra, Inc. | DQY |
| Apr 24, 2006 | K060807 | SCOUTPRO 7F CORONARY SINUS LEAD DELIVERY SYSTEM Biotronik, Inc. | DQY |
| Apr 12, 2006 | K060327 | VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER AND SKYWAY SUPPORT CATHETER Vascular Solutions, Inc. | DQY |
| Apr 4, 2006 | K060655 | SCOUTPRO 8F, MODELS 342 262; HEMOSTATIC VALVE, MODELS 345 968; HOOK GUIDING CATHETER, MODELS 342 263; MULTI-PURPOSE H Biotronik, Inc. | DQY |
| Mar 16, 2006 | K053431 | ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM Medtronic, Ireland | DQY |
| Mar 15, 2006 | K060572 | MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM Boston Scientific Corporation | DQY |
| Mar 15, 2006 | K060418 | 8F SHERPA NX GUIDE CATHETER Medtronic Vascular | DQY |
| Mar 8, 2006 | K053217 | CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148 St Jude Medical | DQY |
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