FDA Product Code
FDA Product Code DQY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1250
510(k) Clearances — 896 records · page 6 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K053277 | CPS DIRECT SL OUTER CATHETER | St Jude Medical | 2006-02-24 | Traditional | PDF ↗ |
| K052004 | VASCON NEUROPATH GUIDING CATHETER | Vascon, LLC | 2006-01-19 | Traditional | PDF ↗ |
| K053118 | STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX | Boston Scientific Corp | 2005-12-16 | Traditional | PDF ↗ |
| K053116 | STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX | Boston Scientific Corp | 2005-12-16 | Traditional | PDF ↗ |
| K052258 | VASCULAR SOLUTIONS SKYWAY SUPPORT CATHETER | Vascular Solutions, Inc. | 2005-12-13 | Traditional | PDF ↗ |
| K052257 | VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER | Vascular Solutions, Inc. | 2005-11-23 | Traditional | PDF ↗ |
| K052791 | MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER | Invatec Innovative Technologies, S.R.L. | 2005-11-04 | Special | PDF ↗ |
| K051580 | VP SHEATH | Flowcardia, Inc. | 2005-10-31 | Traditional | PDF ↗ |
| K051772 | ASAHI TORNUS SUPPORT CATHETER | Asahi Intecc Co., Ltd. | 2005-09-26 | Traditional | PDF ↗ |
| K052149 | EDWARDS PERIPHERAL DILATION CATHETER | Edwards Lifesciences, LLC | 2005-09-02 | Special | PDF ↗ |
| K051838 | MODIFIED CONCENTRIC RETRIEVER, MODEL 90039 | Concentric Medical, Inc. | 2005-09-01 | Special | PDF ↗ |
| K052036 | ATB ADVANCE PTA DILATATION CATHETER | Cook, Inc. | 2005-08-25 | Special | PDF ↗ |
| K052236 | BARD ATLAS PTA BALLOON DILATATION CATHETER | Bard Peripheral Vascular, Inc. | 2005-08-23 | Special | PDF ↗ |
| K051846 | 7F SHERPA NX GUIDE CATHETER | Medtronic Vascular | 2005-08-05 | Special | PDF ↗ |
| K051343 | MINI GHOST PTA CATHETER, MODEL 507 | NuMED, Inc. | 2005-07-28 | Special | PDF ↗ |
| K050599 | TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER | Boston Scientific Corp | 2005-06-03 | Special | PDF ↗ |
| K051060 | ANGIODYNAMICS PROFILER PTA BALLOON CATHETER | AngioDynamics, Inc. | 2005-05-26 | Special | PDF ↗ |
| K050389 | ULTRA-SOFT SV BALLOON DILATATION CATHETER | Boston Scientific Corp | 2005-05-25 | Traditional | PDF ↗ |
| K043489 | ENPATH DEFLECTABLE CATHETER | Enpath Medical Incorporated | 2005-05-19 | Traditional | PDF ↗ |
| K050038 | RELIANT STENT GRAFT BALLOON CATHETER | Medtronic Endovascular Innovations | 2005-04-13 | Traditional | PDF ↗ |
| K043580 | ALLIGATOR RETRIEVAL DEVICE (ARD) | Chestnut Medical Technologies, Inc. | 2005-03-24 | Traditional | PDF ↗ |
| K042553 | BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER | Biocardia, Inc. | 2005-02-17 | Traditional | PDF ↗ |
| K043387 | VASCON POLARIS GUIDING CATHETER | Vascon, LLC | 2005-02-16 | Traditional | PDF ↗ |
| K050073 | MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER | Invatec Innovative Technologies, S.R.L. | 2005-02-11 | Special | PDF ↗ |
| K043534 | MODIFICATION TO OUTBACK CATHETER | Lumend, Inc. | 2005-01-21 | Special | PDF ↗ |
| K042624 | AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER | Invatec Innovative Technologies, S.R.L. | 2005-01-10 | Traditional | PDF ↗ |
| K042117 | PROXIS SYSTEM, MODEL EPS 101 | Velocimed, Inc. | 2005-01-07 | Special | PDF ↗ |
| K042381 | CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508 | Acumen Medical, Inc. | 2004-12-28 | Traditional | PDF ↗ |
| K042489 | 6F Z4 GUIDE CATHETER | Medtronic Vascular | 2004-12-13 | Special | PDF ↗ |
| K042910 | VENTURE WIRE CONTROL CATHETER, MODEL WCC | Velocimed, Inc. | 2004-11-22 | Special | PDF ↗ |
| K042538 | SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX | Invatec Innovative Technologies | 2004-11-08 | Traditional | PDF ↗ |
| K042537 | SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SUVXXXXXXXXX | Invatec Innovative Technologies | 2004-11-08 | Traditional | PDF ↗ |
| K042230 | POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM | Cryo Vascular Systems, Inc. | 2004-11-05 | Traditional | PDF ↗ |
| K042388 | RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE | Radiant Medical | 2004-10-28 | Traditional | PDF ↗ |
| K042568 | EXCELSIOR 1018 AND SL-10 MICROCATHETERS | Boston Scientific Corp | 2004-10-15 | Special | PDF ↗ |
| K042541 | MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM | Cryo Vascular Systems, Inc. | 2004-10-12 | Special | PDF ↗ |
| K042194 | ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY | Medtronic Vascular | 2004-09-15 | Traditional | PDF ↗ |
| K040922 | VENTURE WIRE CONTROL CATHETER | Velocimed, Inc. | 2004-08-18 | Traditional | PDF ↗ |
| K040745 | MODIFIED CONCENTRIC RETRIEVER, MODEL 90038 | Concentric Medical, Inc. | 2004-08-11 | Traditional | PDF ↗ |
| K041151 | KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES | Kerberos Proximal Solutions, Inc. | 2004-07-22 | Traditional | PDF ↗ |
| K040700 | CONCENTRIC RETRIEVER X5, MODEL 90035; CONCENTRIC RETRIEVER X6, MODEL 90037 | Concentric Medical, Inc. | 2004-06-21 | Special | PDF ↗ |
| K033540 | TRANSXCHANGE SUPPORT CATHETER | Medtronic Vascular | 2004-05-25 | Traditional | PDF ↗ |
| K041093 | NUMED MULLINS X PTA CATHETER | NuMED, Inc. | 2004-05-06 | Special | PDF ↗ |
| K033670 | GORE TRI-LOBE BALLOON CATHETER | W. L. Gore & Associates, Inc. | 2004-05-05 | Traditional | PDF ↗ |
| K040771 | MODIFICATION TO OUTBACK CATHETER | Lumend, Inc. | 2004-04-23 | Special | PDF ↗ |
| K033875 | ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER | Cook, Inc. | 2004-04-02 | Traditional | PDF ↗ |
| K040481 | SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1 | Intra Luminal Therapeutics, Inc. | 2004-03-18 | Special | PDF ↗ |
| K033678 | SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038 | Spectranetics Corp. | 2004-02-23 | Traditional | PDF ↗ |
| K033633 | VASCON POLARIS GUIDING CATHETER | Vascon, LLC | 2004-02-18 | Traditional | PDF ↗ |
| K040243 | BARD ATLAS PTA BALLOON DILATATION CATHETER | C.R. Bard, Inc. | 2004-02-13 | Special | PDF ↗ |
| K033622 | POLARCATH PERIPHERAL DILATATION SYSTEM | Cryo Vascular Systems, Inc. | 2004-02-10 | Special | PDF ↗ |
| K033989 | MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69 | Medtronic Inc. Cardiac Rhythm Management | 2004-01-22 | Special | PDF ↗ |
| K033441 | BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER | Boston Scientific Corp | 2003-11-21 | Special | PDF ↗ |
| K033320 | SCOUT PRO | Biotronik, Inc. | 2003-11-19 | Special | PDF ↗ |
| K032869 | COOK CODA BALLOON CATHETER | Cook, Inc. | 2003-11-19 | Traditional | PDF ↗ |
| K032784 | ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 | Intra Luminal Therapeutics, Inc. | 2003-11-18 | Traditional | PDF ↗ |
| K033217 | PHERON PTA CATHETER | Biotronik, Inc. | 2003-10-31 | Traditional | PDF ↗ |
| K032660 | XTRAK SUPPORT CATHETER | Xtrak Medical, Inc. | 2003-10-29 | Traditional | PDF ↗ |
| K032931 | PTA BALLOON CATHETER | Cook, Inc. | 2003-10-22 | Special | PDF ↗ |
| K032312 | ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM | Medtronic Vascular | 2003-10-21 | Special | PDF ↗ |
| K032737 | CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA | Cordis Europa, N.V. | 2003-10-02 | Special | PDF ↗ |
| K032587 | EDWARDS PERIPHERAL DILATATION CATHETER | Edwards Lifesciences, LLC | 2003-10-02 | Traditional | PDF ↗ |
| K032591 | NUMED TYSHAK MINI PEDIATRIC PTV CATHETER | NuMED, Inc. | 2003-09-25 | Special | PDF ↗ |
| K032622 | ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS | Medtronic Vascular | 2003-09-03 | Special | PDF ↗ |
| K030630 | EDWARDS DIRECTIONAL CATHETER | Edwards Lifesciences, LLC | 2003-09-03 | Traditional | PDF ↗ |
| K032069 | WORKHORSE II PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER | AngioDynamics, Inc. | 2003-08-27 | Special | PDF ↗ |
| K032298 | MODIFICATION TO OUTBACK CATHETER | Lumend, Inc. | 2003-08-26 | Special | PDF ↗ |
| K031692 | SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 | Intra Luminal Therapeutics, Inc. | 2003-08-22 | Traditional | PDF ↗ |
| K023548 | PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101 | Velocimed | 2003-08-04 | Traditional | PDF ↗ |
| K030671 | MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB | Medtronic Vascular | 2003-07-31 | Traditional | PDF ↗ |
| K031459 | RAPIDO CUT-AWAY CUTTER | Guidant Corp. | 2003-07-23 | Traditional | PDF ↗ |
| K031211 | ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH | Medtronic Vascular | 2003-07-17 | Traditional | PDF ↗ |
| K031417 | ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1 | Intra Luminal Therapeutics, Inc. | 2003-07-11 | Traditional | PDF ↗ |
| K031766 | ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER | Cook, Inc. | 2003-06-26 | Special | PDF ↗ |
| K031505 | RAPIDO CUT-AWAY GUIDING CATHETER | Guidant Corporation | 2003-06-25 | Special | PDF ↗ |
| K030589 | MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS | NuMED, Inc. | 2003-05-21 | Special | PDF ↗ |
| 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. | 2003-04-24 | Special | PDF ↗ |
| K030779 | 5F MEDTRONIC LAUNCHER GUIDE CATHETER | Medtronic Vascular | 2003-04-24 | Special | PDF ↗ |
| K030715 | SAFFRON NM GUIDING CATHETER | Neich Medical (Shenzhen) Company Limited | 2003-04-24 | Traditional | PDF ↗ |
| K021802 | STEREOTAXIS CATHETER ADVANCER SYSTEM | Stereotaxis, Inc. | 2003-04-08 | Traditional | PDF ↗ |
| K024327 | SETPOINT ENDOVASCULAR TEMPERATURE PROBE | Radiant Medical | 2003-03-25 | Traditional | PDF ↗ |
| K030476 | MODIFIED CONCENTRIC RETRIEVER, MODEL 90037 | Concentric Medical, Inc. | 2003-03-11 | Special | PDF ↗ |
| K023463 | CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNIT | Cryo Vascular Systems, Inc. | 2003-02-19 | Traditional | PDF ↗ |
| K024032 | ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY | Medtronic Vascular | 2002-12-30 | Special | PDF ↗ |
| K024035 | ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY | Medtronic Vascular | 2002-12-30 | Special | PDF ↗ |
| K023320 | AGILTRAC .035 PERIPHERAL DILATATION CATHETER | Guidant Corp. | 2002-12-10 | Traditional | PDF ↗ |
| K023402 | 8F LAUNCHER GUIDE CATHETER | Medtronic Vascular | 2002-11-06 | Special | PDF ↗ |
| K023223 | MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER | Lumend, Inc. | 2002-10-24 | Special | PDF ↗ |
| K022552 | ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER | Cook, Inc. | 2002-09-27 | Special | PDF ↗ |
| K022138 | SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028 | Spectranetics Corp. | 2002-09-23 | Traditional | PDF ↗ |
| K022061 | CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER | Cryo Vascular Systems, Inc. | 2002-09-20 | Traditional | PDF ↗ |
| K022722 | PTA AND PTV | NuMED, Inc. | 2002-09-13 | Special | PDF ↗ |
| K022738 | AGILTRAC .035 PERIPHERAL DILATATION CATHETER | Guidant Corp. | 2002-09-13 | Special | PDF ↗ |
| K022764 | 7F LAUNCHER GUIDE CATHETER | Medtronic Vascular | 2002-08-28 | Special | PDF ↗ |
| K021735 | BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER | Boston Scientific Scimed, Inc. | 2002-08-08 | Traditional | PDF ↗ |
| K021455 | RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782, | Guidant Corp. | 2002-08-02 | Traditional | PDF ↗ |
| K021899 | CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072 | Concentric Medical, Inc. | 2002-07-10 | Special | PDF ↗ |
| K021721 | EQUALIZER BALLOON CATHETER | Boston Scientific Corp | 2002-06-20 | Special | PDF ↗ |
| K021593 | MODIFICATION TO ENVOY AND VISTA BRITE TIP | Cordis Corp. | 2002-06-13 | Special | PDF ↗ |
| K021587 | ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A | Medtronic Vascular | 2002-05-30 | Special | PDF ↗ |
Product code DQY · Class II · Cardiovascular. Data: openFDA.