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 7 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K021589 | ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218 | Medtronic Vascular | 2002-05-30 | Special | PDF ↗ |
| K021256 | Z3 GUIDE CATHETER | Medtronic Vascular | 2002-05-17 | Special | PDF ↗ |
| K021120 | RADIAL ARTERY CATHERIZATION SET WITH INTEGRAL NEEDLE PROTECTION,MODEL RA-04020-SP | Arrow Intl., Inc. | 2002-05-02 | Special | PDF ↗ |
| K021284 | EASYTRAK GUIDING CATHETER | Guidant Corp. | 2002-05-02 | Traditional | PDF ↗ |
| K021088 | JOGUIDE CARDIOVASCULAR GUIDING C ATHETER | Jomed Catheter, Inc. | 2002-05-02 | Special | PDF ↗ |
| K013517 | 10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600 | Medtronic Vascular | 2002-04-25 | Traditional | PDF ↗ |
| K013963 | MODEL 9210 DELIVERY CATHETER, MODEL 9210 | Medtronic Vascular | 2002-02-28 | Traditional | PDF ↗ |
| K020161 | AGILTRAC .018 PERIPHERAL DILATATION CATHETER | Guidant Corp. | 2002-02-22 | Special | PDF ↗ |
| K013284 | LUMEND FRONTRUNNER CTO CORONARY CATHETER | Lumend, Inc. | 2002-02-11 | Traditional | PDF ↗ |
| K020028 | 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX | Boston Scientific | 2002-01-22 | Special | PDF ↗ |
| K014212 | BARD CONQUEST PTA BALLOON DILATATION CATHETER | C.R. Bard, Inc. | 2002-01-17 | Special | PDF ↗ |
| K011562 | LUMEND PERCUTANEOUS CATHETER | Lumend, Inc. | 2002-01-16 | Traditional | PDF ↗ |
| K014118 | MODIFICATION TO SUPERCROSS CATHETER | Abbott Vascular, Inc. | 2002-01-11 | Special | PDF ↗ |
| K014117 | MODIFICATION TO OUTBACK CATHETER | Lumend, Inc. | 2002-01-11 | Special | PDF ↗ |
| K013601 | NUMED MULLINS PTA CATHETER | NuMED, Inc. | 2002-01-03 | Special | PDF ↗ |
| K011889 | ULTRA -THIN SDS BALLOON DILATATION CATHETER | Boston Scientific Corp | 2001-12-21 | Traditional | PDF ↗ |
| K013789 | EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 | Boston Scientific, Target | 2001-12-06 | Special | PDF ↗ |
| K013638 | MODIFICATION TO VIKING OPTIMA GUIDING CATHETER | Guidant Corp. | 2001-12-04 | Special | PDF ↗ |
| K013581 | CORDIS AVIATOR PERIPHERAL DILATATION CATHETER | Cordis, A Johnson & Johnson Co. | 2001-11-28 | Special | PDF ↗ |
| K010579 | STENT SUPPORT GUIDE CATHETER | Medtronic Vascular | 2001-11-21 | Traditional | PDF ↗ |
| K010954 | CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031 | Concentric Medical, Inc. | 2001-10-09 | Traditional | PDF ↗ |
| K012913 | BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER | C.R. Bard, Inc. | 2001-09-28 | Special | PDF ↗ |
| K012050 | VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER | Guidant Corp. | 2001-09-06 | Special | PDF ↗ |
| K012169 | ILT SUPPORT CATHETER .014, MODEL C114LW1; ILT SUPPORT CATHETER ADVANCING MECHANISM, MODEL A11AM1 | Intra Luminal Therapeutics, Inc. | 2001-08-30 | Special | PDF ↗ |
| K012130 | ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM | Medtronic Vascular | 2001-08-28 | Traditional | PDF ↗ |
| K012083 | ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218 | Medtronic Vascular | 2001-08-28 | Traditional | PDF ↗ |
| K012002 | VIKING OPTIMA GUIDING CATHETER | Guidant Corp. | 2001-07-26 | Special | PDF ↗ |
| K010838 | FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A14004, A14005, A14006, A14007, A14008 | Jomed AG | 2001-06-21 | Traditional | PDF ↗ |
| K010874 | 6F MACH 1, MODEL 34356-XXX | Boston Scientific Corp | 2001-06-21 | Traditional | PDF ↗ |
| K003920 | CORDIS M3 PTA DILATATION CATHETER | Cordis Corp. | 2001-06-15 | Abbreviated | PDF ↗ |
| K010831 | AVIATOR PERIPHERAL DILATATION CATHETER | Guidant Corp. | 2001-06-13 | Special | PDF ↗ |
| K011464 | RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER, RX HERCULINK 14 BILIARY STN | Vascular Intervention | 2001-06-13 | Special | PDF ↗ |
| K003410 | CONCENTRIC RETRIEVER, MODEL 90030 | Concentric Medical, Inc. | 2001-05-22 | Traditional | PDF ↗ |
| K003880 | CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F) | Concentric Medical, Inc. | 2001-05-16 | Abbreviated | PDF ↗ |
| K001694 | GUIDANT RETRIEVER DEVICE | Guidant Cardiac and Vascular Surgery | 2001-05-15 | Traditional | PDF ↗ |
| K010880 | NUMED HIGH PRESSURE PTA CATHETERS | NuMED, Inc. | 2001-04-20 | Special | PDF ↗ |
| K010531 | ILT DEFLECTING CATHETER, MODEL C114ND1 | Intra Luminal Therapeutics, Inc. | 2001-04-18 | Special | PDF ↗ |
| K010853 | GUIDER SOFTIP GUIDING CATHETER XF 5F | Boston Scientific, Target | 2001-04-18 | Special | PDF ↗ |
| K001856 | SUPERCROSS CATHETER | Abbott Vascular, Inc. | 2001-03-07 | Traditional | PDF ↗ |
| K003085 | CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020 | Concentric Medical, Inc. | 2001-03-07 | Traditional | PDF ↗ |
| K010169 | BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER | C.R. Bard, Inc. | 2001-02-13 | Special | PDF ↗ |
| K003495 | ANCURE LLIAC BALLOON CATHETER | Guidant Cardiac and Vascular Surgery | 2001-02-07 | Traditional | PDF ↗ |
| K001577 | OUTBACK CATHETER | Lumend, Inc. | 2001-01-11 | Traditional | PDF ↗ |
| K003643 | NUMED Z-MED PTV CATHERERS | NuMED, Inc. | 2000-12-27 | Special | PDF ↗ |
| K001992 | ILT 0.014 CATHETER, MODEL C114NL2 | Intra Luminal Therapeutics, Inc. | 2000-09-25 | Traditional | PDF ↗ |
| K001969 | GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300 | Medtronic Vascular | 2000-08-16 | Special | PDF ↗ |
| K001435 | VIKING OPTIMA GUIDING CATHETER | Guidant Corp. | 2000-06-02 | Special | PDF ↗ |
| K001136 | CORDIS INTRODUCER GUIDE | Cordis Corp. | 2000-04-28 | Special | PDF ↗ |
| K000715 | ENVOY AND VISTA BRITE TIP | Cordis Corp. | 2000-03-31 | Special | PDF ↗ |
| K000677 | ZUMA GUIDE CATHETERS | Medtronic Vascular | 2000-03-29 | Special | PDF ↗ |
| K000598 | 5F GUIDING CATHETER | Guidant Corp. | 2000-03-24 | Special | PDF ↗ |
| K994229 | VERIPATH PERIPHERAL GUIDING CATHETER | Advanced Cardiovascular Systems, Inc. | 2000-02-25 | Special | PDF ↗ |
| K991059 | SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017 | Spectranetics Corp. | 1999-11-16 | Traditional | PDF ↗ |
| K991601 | DUAL LUMEN CATHETER, MODEL DL-35-90 | Endologix, Inc. | 1999-10-28 | Traditional | PDF ↗ |
| K992673 | VISTA BRITE TIP CATHETERS | Cordis Corp. | 1999-10-12 | Traditional | PDF ↗ |
| K992622 | INTRAMAX ITI GUIDE CATHETER | Intratherapeutics, Inc. | 1999-09-29 | Special | PDF ↗ |
| K984482 | AVE GL-1 GUIDING CATHETER | Arterial Vascular Engineering Massachusetts, Inc. | 1999-07-30 | Traditional | PDF ↗ |
| K974683 | NAVIPORT DEFLECTABLE TIP GUIDING CATHETER | Cardima, Inc. | 1999-06-22 | Traditional | PDF ↗ |
| K981191 | ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65 | Intratherapeutics, Inc. | 1999-04-07 | Traditional | PDF ↗ |
| K990726 | ENVY GUIDING CATHETER | Cook, Inc. | 1999-04-02 | Special | PDF ↗ |
| K990707 | MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS | Medtronics Interventional Vascular | 1999-03-22 | Special | PDF ↗ |
| K981359 | GT LEGGIERO | Terumo Medical Corp. | 1999-01-27 | Traditional | PDF ↗ |
| K972065 | AURORA | Neurovena Corp. | 1999-01-27 | Traditional | PDF ↗ |
| K980278 | URESIL VASCU-FLO INFUSION CATHETER | Uresil Corp. | 1998-11-20 | Traditional | PDF ↗ |
| K982883 | MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER | Medtronics Interventional Vascular | 1998-09-04 | Special | PDF ↗ |
| K982632 | ENVOY AND VISTA BRITE TIP | Cordis Corp. | 1998-08-18 | Special | PDF ↗ |
| K982770 | 6F ENVOY GUIDING CATHETER | Cordis Corp. | 1998-08-18 | Special | PDF ↗ |
| K980453 | SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS | Boston Scientific Scimed, Inc. | 1998-08-11 | Traditional | PDF ↗ |
| K981198 | MEDTRONIC ZUMA GUIDING CATHETER | Medtronics Interventional Vascular | 1998-08-07 | Traditional | PDF ↗ |
| K973298 | CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER | Cardima, Inc. | 1998-06-26 | Traditional | PDF ↗ |
| K970668 | THE AMPLANTZ GOOSE NECK MICROSNARE | Microvena Corp. | 1998-06-10 | Traditional | PDF ↗ |
| K981413 | SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS | Boston Scientific Scimed, Inc. | 1998-05-13 | Special | PDF ↗ |
| K974684 | SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER | Scimed Life Systems, Inc. | 1998-02-19 | Traditional | PDF ↗ |
| K973371 | CERTODYN RAECG UNIVERSAL ADAPTER | B.Braun Medical, Inc. | 1997-11-24 | Traditional | PDF ↗ |
| K972978 | VISTA BRITE TIP GUIDING CATHETERS | Cordis Corp. | 1997-10-21 | Traditional | PDF ↗ |
| K972484 | ACS VIKING GUIDING CATHETER | Guidant Corp. | 1997-09-26 | Traditional | PDF ↗ |
| K970401 | MEDI-DYNE GUIDING CATHETER | Medi-Dyne, Inc. | 1997-08-01 | Traditional | PDF ↗ |
| K965247 | ENVOY GUIDING CATHETER | Cordis Neurovascular, Inc. | 1997-07-23 | Traditional | PDF ↗ |
| K971572 | VISTA BRITE TIP CATHETERS | Cordis Corp. | 1997-07-14 | Traditional | PDF ↗ |
| K970823 | SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER | Scimed Life Systems, Inc. | 1997-06-03 | Traditional | PDF ↗ |
| K963962 | VISTA BRITE TIP CATHETERS | Cordis Corp. | 1997-05-07 | Traditional | PDF ↗ |
| K965211 | VISTA BRITE TIP CATHETERS | Cordis Corp. | 1997-03-11 | Traditional | PDF ↗ |
| K962717 | 6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING | Biocompatibles Cardiovascular, Inc. | 1997-02-12 | Traditional | PDF ↗ |
| K963663 | 11F GUIDING CATHETER | Boston Scientific /International Technologies | 1997-01-13 | Traditional | PDF ↗ |
| K962830 | VISTA BRITE TIP CATHETERS | Cordis Corp. | 1996-10-17 | Traditional | PDF ↗ |
| K962362 | CORDIS ENVOY & VISTA BRITE TIP GUIDING CATHETERS | Cordis Corp. | 1996-08-08 | Traditional | PDF ↗ |
| K961280 | SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F | Scimed Life Systems, Inc. | 1996-05-15 | Traditional | PDF ↗ |
| K955651 | MEDTRONIC SHERPA GUIDING CATHETER | Medtronics Interventional Vascular | 1996-01-22 | Traditional | PDF ↗ |
| K953265 | SCIMED ANGIOGRAPHIC KITS | Scimed Life Systems, Inc. | 1996-01-16 | Traditional | PDF ↗ |
| K953987 | ACS TOURGIDE GUIDING CATHETER | Advanced Cardiovascular Systems, Inc. | 1995-12-07 | Traditional | PDF ↗ |
| K950490 | MEDTRONIC GC IV CORONARY GUIDING CATHETER | Medtronics Interventional Vascular | 1995-11-21 | Traditional | PDF ↗ |
| K953909 | SCIMED 6 FRENCH MICRO-MAX GUIDE CATHETER | Scimed | 1995-11-13 | Traditional | PDF ↗ |
| K954251 | 5F ENVOY GUIDING CATHETER (MODIFICATION) | Cordis Neurovascular, Inc. | 1995-10-23 | Traditional | PDF ↗ |
| K951603 | CARDIMA, INC. FORERUNNER | Cardima, Inc. | 1995-10-05 | Traditional | PDF ↗ |
| K951159 | FASGUIDE | Target Therapeutics | 1995-09-25 | Traditional | PDF ↗ |
| K953515 | SCIMED TRIGUIDE GUIDE CATHETERS | Scimed Life Systems, Inc. | 1995-09-19 | Traditional | PDF ↗ |
| K952345 | MEDI-TECH PLATFORM GUIDE CATHETER | Medi-Tech, Inc. | 1995-08-17 | Traditional | PDF ↗ |
| K952205 | ACS POWERBASE GUILDING CATHETER | Advanced Cardiovascular Systems, Inc. | 1995-08-04 | Traditional | PDF ↗ |
| K952185 | CORDIS BRITE TIP, ENVOY GUIDING CATHETER | Cordis Corp. | 1995-08-02 | Traditional | PDF ↗ |
| K950179 | MEDTRONIC(R) GC III CORONARY GUIDING CATHETER | Medtronics Interventional Vascular | 1995-07-25 | Traditional | PDF ↗ |
Product code DQY · Class II · Cardiovascular. Data: openFDA.