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 24, 2006 | K053277 | CPS DIRECT SL OUTER CATHETER St Jude Medical | DQY |
| Jan 19, 2006 | K052004 | VASCON NEUROPATH GUIDING CATHETER Vascon, LLC | DQY |
| Dec 16, 2005 | K053118 | STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX Boston Scientific Corp | DQY |
| Dec 16, 2005 | K053116 | STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX Boston Scientific Corp | DQY |
| Dec 13, 2005 | K052258 | VASCULAR SOLUTIONS SKYWAY SUPPORT CATHETER Vascular Solutions, Inc. | DQY |
| Nov 23, 2005 | K052257 | VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER Vascular Solutions, Inc. | DQY |
| Nov 4, 2005 | K052791 | MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER Invatec Innovative Technologies, S.R.L. | DQY |
| Oct 31, 2005 | K051580 | VP SHEATH Flowcardia, Inc. | DQY |
| Sep 26, 2005 | K051772 | ASAHI TORNUS SUPPORT CATHETER Asahi Intecc Co., Ltd. | DQY |
| Sep 2, 2005 | K052149 | EDWARDS PERIPHERAL DILATION CATHETER Edwards Lifesciences, LLC | DQY |
| Sep 1, 2005 | K051838 | MODIFIED CONCENTRIC RETRIEVER, MODEL 90039 Concentric Medical, Inc. | DQY |
| Aug 25, 2005 | K052036 | ATB ADVANCE PTA DILATATION CATHETER Cook, Inc. | DQY |
| Aug 23, 2005 | K052236 | BARD ATLAS PTA BALLOON DILATATION CATHETER Bard Peripheral Vascular, Inc. | DQY |
| Aug 5, 2005 | K051846 | 7F SHERPA NX GUIDE CATHETER Medtronic Vascular | DQY |
| Jul 28, 2005 | K051343 | MINI GHOST PTA CATHETER, MODEL 507 NuMED, Inc. | DQY |
| Jun 3, 2005 | K050599 | TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER Boston Scientific Corp | DQY |
| May 26, 2005 | K051060 | ANGIODYNAMICS PROFILER PTA BALLOON CATHETER AngioDynamics, Inc. | DQY |
| May 25, 2005 | K050389 | ULTRA-SOFT SV BALLOON DILATATION CATHETER Boston Scientific Corp | DQY |
| May 19, 2005 | K043489 | ENPATH DEFLECTABLE CATHETER Enpath Medical Incorporated | DQY |
| Apr 13, 2005 | K050038 | RELIANT STENT GRAFT BALLOON CATHETER Medtronic Endovascular Innovations | DQY |
| Mar 24, 2005 | K043580 | ALLIGATOR RETRIEVAL DEVICE (ARD) Chestnut Medical Technologies, Inc. | DQY |
| Feb 17, 2005 | K042553 | BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER Biocardia, Inc. | DQY |
| Feb 16, 2005 | K043387 | VASCON POLARIS GUIDING CATHETER Vascon, LLC | DQY |
| Feb 11, 2005 | K050073 | MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER Invatec Innovative Technologies, S.R.L. | DQY |
| Jan 21, 2005 | K043534 | MODIFICATION TO OUTBACK CATHETER Lumend, Inc. | DQY |
| Jan 10, 2005 | K042624 | AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER Invatec Innovative Technologies, S.R.L. | DQY |
| Jan 7, 2005 | K042117 | PROXIS SYSTEM, MODEL EPS 101 Velocimed, Inc. | DQY |
| Dec 28, 2004 | K042381 | CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508 Acumen Medical, Inc. | DQY |
| Dec 13, 2004 | K042489 | 6F Z4 GUIDE CATHETER Medtronic Vascular | DQY |
| Nov 22, 2004 | K042910 | VENTURE WIRE CONTROL CATHETER, MODEL WCC Velocimed, Inc. | DQY |
| Nov 8, 2004 | K042538 | SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX Invatec Innovative Technologies | DQY |
| Nov 8, 2004 | K042537 | SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SUVXXXXXXXXX Invatec Innovative Technologies | DQY |
| Nov 5, 2004 | K042230 | POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM Cryo Vascular Systems, Inc. | DQY |
| Oct 28, 2004 | K042388 | RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE Radiant Medical | DQY |
| Oct 15, 2004 | K042568 | EXCELSIOR 1018 AND SL-10 MICROCATHETERS Boston Scientific Corp | DQY |
| Oct 12, 2004 | K042541 | MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM Cryo Vascular Systems, Inc. | DQY |
| Sep 15, 2004 | K042194 | ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY Medtronic Vascular | DQY |
| Aug 18, 2004 | K040922 | VENTURE WIRE CONTROL CATHETER Velocimed, Inc. | DQY |
| Aug 11, 2004 | K040745 | MODIFIED CONCENTRIC RETRIEVER, MODEL 90038 Concentric Medical, Inc. | DQY |
| Jul 22, 2004 | K041151 | KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES Kerberos Proximal Solutions, Inc. | DQY |
| Jun 21, 2004 | K040700 | CONCENTRIC RETRIEVER X5, MODEL 90035; CONCENTRIC RETRIEVER X6, MODEL 90037 Concentric Medical, Inc. | DQY |
| May 25, 2004 | K033540 | TRANSXCHANGE SUPPORT CATHETER Medtronic Vascular | DQY |
| May 6, 2004 | K041093 | NUMED MULLINS X PTA CATHETER NuMED, Inc. | DQY |
| May 5, 2004 | K033670 | GORE TRI-LOBE BALLOON CATHETER W. L. Gore & Associates, Inc. | DQY |
| Apr 23, 2004 | K040771 | MODIFICATION TO OUTBACK CATHETER Lumend, Inc. | DQY |
| Apr 2, 2004 | K033875 | ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER Cook, Inc. | DQY |
| Mar 18, 2004 | K040481 | SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1 Intra Luminal Therapeutics, Inc. | DQY |
| Feb 23, 2004 | K033678 | SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038 Spectranetics Corp. | DQY |
| Feb 18, 2004 | K033633 | VASCON POLARIS GUIDING CATHETER Vascon, LLC | DQY |
| Feb 13, 2004 | K040243 | BARD ATLAS PTA BALLOON DILATATION CATHETER C.R. Bard, Inc. | DQY |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.