FDA Product Code
FDA Product Code KRA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1210
510(k) Clearances — 177 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K023351 | MAGIC INFUSION CATHETER | Advanced Interventional Technologies, LLC | 2003-02-20 | Traditional | PDF ↗ |
| K024118 | ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066 | Micro Therapeutics, Inc. | 2003-02-03 | Special | PDF ↗ |
| K021591 | PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS | Cordis Neurovascular, Inc. | 2002-05-22 | Special | PDF ↗ |
| K020680 | PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS | Cordis Neurovascular, Inc. | 2002-03-27 | Special | PDF ↗ |
| K020733 | PVS 1500 SDS | Precision Vascular Systems, Inc. | 2002-03-21 | Traditional | PDF ↗ |
| K011646 | NEUROEDGE INFUSION CATHETER | Neuro Vasx, Inc. | 2001-08-27 | Traditional | PDF ↗ |
| K010004 | FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065 | Micro Therapeutics, Inc. | 2001-02-13 | Special | PDF ↗ |
| K003925 | PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS | Cordis Neurovascular, Inc. | 2001-01-08 | Special | PDF ↗ |
| K002723 | REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS; REBAR MICRO CATHETER: REBAR-10 (1.7F), 170 CM, DUAL MA | Micro Therapeutics, Inc. | 2000-09-28 | Special | PDF ↗ |
| K994155 | EXCELSIOR 1018 MICROCATHETER | Boston Scientific, Target | 2000-08-03 | Traditional | PDF ↗ |
| K001966 | REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND | Micro Therapeutics, Inc. | 2000-07-20 | Special | PDF ↗ |
| K000177 | RENEGADE HI-FLO MICROCATHETER | Boston Scientific Corp | 2000-04-07 | Traditional | PDF ↗ |
| K993672 | REBAR MICRO CATHETER, MODELS 105-5080, 105-5086 | Micro Therapeutics, Inc. | 2000-01-04 | Special | PDF ↗ |
| K993266 | PROWLER PLUS INFUSION CATHETER | Cordis Neurovascular, Inc. | 1999-10-28 | Special | PDF ↗ |
| K983003 | 1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS | Cordis Neurovascular, Inc. | 1998-09-17 | Special | PDF ↗ |
| K974473 | EASY RIDER MICRO CATHETER | Micro Therapeutics, Inc. | 1998-06-17 | Traditional | PDF ↗ |
| K980104 | FLOW RIDER FLOW DIRECTED MICRO CATHETER | Micro Therapeutics, Inc. | 1998-04-10 | Traditional | PDF ↗ |
| K971619 | MICROFUSE MEMBRANE INFUSION CATHETER | E-Med Corp. | 1998-02-27 | Traditional | PDF ↗ |
| K974222 | CES MASSTRANSIT INFUSION CATHETER | Cordis Neurovascular, Inc. | 1998-02-10 | Traditional | PDF ↗ |
| K973645 | RENEGADE FIBER BRAIDED MICROCATHETER | Boston Scientific Corp | 1997-11-19 | Traditional | PDF ↗ |
| K972518 | TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER | Cordis Neurovascular, Inc. | 1997-11-04 | Traditional | PDF ↗ |
| K971306 | FG INFUSION CATHETER | Cordis Neurovascular, Inc. | 1997-07-14 | Traditional | PDF ↗ |
| K964868 | 2.9F CRAGG-MCNAMARA VALVED INFUSION CATHETER | Micro Therapeutics, Inc. | 1997-05-20 | Traditional | PDF ↗ |
| K962129 | CONTINUOUS FLUSH DEVICE | Merit Medical Systems, Inc. | 1997-04-15 | Traditional | PDF ↗ |
| K965189 | SPINNAKER | Target Therapeutics | 1997-03-24 | Traditional | PDF ↗ |
| K965181 | CES INFUSION CATHETER | Cordis Neurovascular, Inc. | 1997-03-21 | Traditional | PDF ↗ |
| K964154 | SEGUE INFUSION CATHETER | Interventional Innovations Corp. | 1997-01-14 | Traditional | PDF ↗ |
| K963988 | INTRAVASCULAR INFUSION DEVICE | Boston Scientific Corp | 1996-12-12 | Traditional | PDF ↗ |
| K961668 | MICROFERRET CATHETER | Cook, Inc. | 1996-11-04 | Traditional | PDF ↗ |
| K955525 | FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70 | Interventional Innovations Corp. | 1996-08-08 | Traditional | PDF ↗ |
| K955534 | SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60) | International Innovations, Inc. | 1996-08-01 | Traditional | PDF ↗ |
| K961294 | SCIMED DISPATCH GOLD CORONARY CATHETER | Scimed Life Systems, Inc. | 1996-07-03 | Traditional | PDF ↗ |
| K961527 | MX703 AND MX730 CONTINUOUS FLUSH DEVICES | Medex, Inc. | 1996-06-06 | Traditional | PDF ↗ |
| K954457 | MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER | Medi-Tech, Inc. | 1996-05-15 | Traditional | PDF ↗ |
| K953133 | SCIMED DISPATCH CORONARY INFUSION CATHETER | Scimed Life Systems, Inc. | 1996-02-23 | Traditional | PDF ↗ |
| K954020 | MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE | Micro Therapeutics, Inc. | 1996-01-02 | Traditional | PDF ↗ |
| K954949 | TRANSIT INFUSION CATHETER WITH SIDEHOLES | Cordis Neurovascular, Inc. | 1995-12-22 | Traditional | PDF ↗ |
| K952874 | TRANSIT INFUSION CATHETER | Cordis Neurovascular, Inc. | 1995-08-21 | Traditional | PDF ↗ |
| K952872 | SSCIMED CORONARY GUIDE WIRE/INFUSION CATHETER | Scimed Life Systems, Inc. | 1995-07-27 | Traditional | PDF ↗ |
| K945666 | EVOLUTION(TM) MICROCATHETER | Boston Scientific Corp | 1995-06-21 | Traditional | PDF ↗ |
| K951602 | PULSE*SPRAY INFUSION SYSTEM | Angiodynamics, Div. E-Z-Em, Inc. | 1995-06-14 | Traditional | PDF ↗ |
| K945909 | NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER | Navarre Biomedical , Ltd. | 1995-06-02 | Traditional | PDF ↗ |
| K945904 | SCIMED(R) VENTURE(TM) II INFUSION CATHETER | Scimed Peripheral Interventions | 1995-05-19 | Traditional | PDF ↗ |
| K951502 | CVD BULLET INFUSION CATYHETER | Cardiovascular Dynamics, Inc. | 1995-05-10 | Traditional | PDF ↗ |
| K951503 | CVD BULLETT HI-FLO INFUSION CATHETER | Cardiovascular Dynamics, Inc. | 1995-05-04 | Traditional | PDF ↗ |
| K945593 | SCIMED(R) CORONARY GUIDE WIRE EXCHANGE/INFUSION CATHETER | Scimed Life Systems, Inc. | 1995-01-13 | Traditional | PDF ↗ |
| K935349 | LOCALMED INFUSION CATHETER | Localmed, Inc. | 1994-10-18 | Traditional | PDF ↗ |
| K931335 | SCIMED(R) VENTURE(TM) INFUSION CATHETER | Scimed Life Systems, Inc. | 1994-07-27 | Traditional | PDF ↗ |
| K932800 | CARDIMA TRACKER(R) INFUSION CATHETER | Cardima, Inc. | 1993-12-21 | Traditional | PDF ↗ |
| K932616 | SCIMED(R) DISPATCH(TM) CORONARY INFUSION CATHETER | Scimed Life Systems, Inc. | 1993-12-15 | Traditional | PDF ↗ |
| K932188 | SAFESET RESERVOIR | Abbott Laboratories | 1993-10-25 | Traditional | PDF ↗ |
| K921247 | ZEPHYR INFUSION CATHETER | Target Therapeutics | 1993-06-29 | Traditional | PDF ↗ |
| K914751 | SELECTIVE INFUSION II CATHETER | Advanced Cardiovascular Systems, Inc. | 1993-05-24 | Traditional | PDF ↗ |
| K924661 | SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER | Baxter Healthcare Corp | 1993-04-08 | Traditional | PDF ↗ |
| K923368 | MAGIC INFUSION CATHETER | Target Therapeutics | 1993-04-07 | Traditional | PDF ↗ |
| K914979 | EDM(R) INFUSION CATHETER | Peripheral Systems Group | 1992-09-16 | Traditional | PDF ↗ |
| K905447 | E-Z-EM PULSED INFUSION SYSTEM | E-Z-Em, Inc. | 1991-04-01 | Traditional | PDF ↗ |
| K896819 | VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION | Baxter Healthcare Corp | 1990-01-19 | Traditional | PDF ↗ |
| K885281 | VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION | Baxter Healthcare Corp | 1989-03-03 | Traditional | PDF ↗ |
| K884946 | JEHLE CORONARY PERFUSION CATHETERS | Pilling Co. | 1989-02-06 | Traditional | PDF ↗ |
| K874242 | JEHLE CORONARY PERFUSION CATHETERS | Pilling Co. | 1987-12-07 | Traditional | PDF ↗ |
| K860570 | ANGIO-FLO CONTINUOUS ARTERIAL CATH FLUSH DEVICE | Parke-Davis Co. | 1986-03-31 | Traditional | PDF ↗ |
| K832058 | ANGIO-FLO CONTIN-ARTERIAL FLUSH DEV. | Parke-Davis Co. | 1983-09-12 | Traditional | PDF ↗ |
| K831730 | CONTINUOUS FLUSH DEVICE | American Pharmaseal Div. Ahsc | 1983-07-18 | Traditional | PDF ↗ |
| K831637 | ACCU-FLUSH | Accu-Line | 1983-06-30 | Traditional | PDF ↗ |
| K812173 | FLUSHFLO II | Bentley Laboratories, Inc. | 1981-08-18 | Traditional | PDF ↗ |
| K811410 | MEDI-TRACE | Graphic Controls Corp. | 1981-06-12 | Traditional | PDF ↗ |
| K801829 | MEDI-TRACE DISP. FLUSHING DEV./MONITOR | Graphic Controls Corp. | 1980-08-27 | Traditional | PDF ↗ |
| K801173 | ANGIO-FLO MONITORING KIT | Hospital Products Co. | 1980-05-28 | Traditional | PDF ↗ |
| K791890 | CONTINUOUS FLUSH DEVICE, CAT. #14-370 | Norton Performance Plastics Corp. | 1979-12-13 | Traditional | PDF ↗ |
| K792141 | CONTINUOUS FLUSH DEVICE | Pharmaseal Div., Baxter Healthcare Corp. | 1979-12-05 | Traditional | PDF ↗ |
| K791844 | CRITIFLO & CRITIFLO DOME | Gould, Inc. | 1979-10-02 | Traditional | PDF ↗ |
| K790455 | MICROFLUSH | Medex, Inc. | 1979-03-23 | Traditional | PDF ↗ |
| K790327 | ANGIO-FLO | Deseret Medical, Inc. | 1979-02-26 | Traditional | PDF ↗ |
| K780479 | DELTA-FLOW | Tri-Delta Intl. | 1978-11-22 | Traditional | PDF ↗ |
| K770432 | MICROFLUSH | Medex, Inc. | 1977-03-16 | Traditional | PDF ↗ |
| K761273 | FLUSHFLO-MODEL CC1-6 | Bentley Laboratories, Inc. | 1977-01-12 | Traditional | PDF ↗ |
Product code KRA · Class II · Cardiovascular. Data: openFDA.