FDA Product Code
FDA Product Code LIT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1250
510(k) Clearances — 405 records · page 4 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K915347 | SCIMED VIPER CATHETER | Scimed | 1992-08-17 | Traditional | PDF ↗ |
| K921856 | TOTAL CROSS .021 PERCUT. TRANSLUMINAL ANGIO. CATH. | Schneider Intl., Ltd. | 1992-07-21 | Traditional | PDF ↗ |
| K921943 | SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO (PTA) BAL | Schneider Intl., Ltd. | 1992-06-17 | Traditional | PDF ↗ |
| K915895 | STEALTH DILATION CATHETER SYSTEM (MODIFIED) | Target Therapeutics | 1992-06-04 | Traditional | PDF ↗ |
| K920547 | ULTRA-THIN | Boston Scientific Corp | 1992-05-06 | Traditional | PDF ↗ |
| K915168 | PROFLEX 5 | Peripheral Systems Group | 1992-02-19 | Traditional | PDF ↗ |
| K915349 | PTA BALLOON CATHETER | Schneider Intl., Ltd. | 1992-02-11 | Traditional | PDF ↗ |
| K914976 | OPTI-PLAST 5F PTA CATHETERS, MODIFICATION | Vas-Cath, Inc. | 1992-01-27 | Traditional | PDF ↗ |
| K914500 | OPTI-PLAST 5F PTA CATHETERS, MODIFICATION | Vas-Cath, Inc. | 1991-12-31 | Traditional | PDF ↗ |
| K913391 | TEGWIRE (TM) | Boston Scientific Corp | 1991-11-05 | Traditional | PDF ↗ |
| K913689 | SUB-4(TM), PERIPHERAL DILATATION CATHETER | Boston Scientific Corp | 1991-10-16 | Traditional | PDF ↗ |
| K913297 | SCHNEIDER MATCH-35(TM) PERCU TRANS ANGIOPLAS CATH | Schneider Intl., Ltd. | 1991-10-10 | Traditional | PDF ↗ |
| K910965 | ECHOMARK CSI INTERFACE | Catheter Sciences Co. | 1991-09-17 | Traditional | PDF ↗ |
| K910822 | BARD PERIPHERAL BALLOON DILATATION CATHETER | C.R. Bard, Inc. | 1991-08-29 | Traditional | PDF ↗ |
| K912317 | SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO PTA CATH | Schneider Intl., Ltd. | 1991-08-22 | Traditional | PDF ↗ |
| K913112 | OPTI-PLAST 5F PTA CATHETERS | Vas-Cath, Inc. | 1991-08-16 | Traditional | PDF ↗ |
| K912984 | OPTI-PLAST 5F PTA CATHETERS, MODIFICATION | Vas-Cath, Inc. | 1991-08-13 | Traditional | PDF ↗ |
| K911870 | SCIMED OPTAMUM OPERATIVE PERIPHERAL ANGIOPLAS CATH | Scimed Life Systems, Inc. | 1991-08-12 | Traditional | PDF ↗ |
| K905698 | CORDIS OPTA 5 | Cordis Corp. | 1991-07-09 | Traditional | PDF ↗ |
| K911639 | OPTI-PLAST 5F PTA CATHETERS OVEN CURING PROCEDURE | Vas-Cath, Inc. | 1991-06-11 | Traditional | PDF ↗ |
| K911196 | SCHNEIDER TOTAL CROSS .021 PERCU TRANS ANGIO (PTA) | Schneider Intl., Ltd. | 1991-06-10 | Traditional | PDF ↗ |
| K911130 | HEMOSTATIC Y CONNECTOR | Thomas Medical Products, Inc. | 1991-06-06 | Traditional | PDF ↗ |
| K911215 | GESCO PER-Q-CATH NEEDLE | Gesco Intl., Inc. | 1991-06-06 | Traditional | PDF ↗ |
| K911089 | STEALTH CATHETER SYSTEM | Target Therapeutics | 1991-05-29 | Traditional | PDF ↗ |
| K904984 | ADVANCE 418(TM) | Peripheral Systems Group | 1991-04-12 | Traditional | PDF ↗ |
| K910996 | OPTI-PLAST 5F PTA CATHETERS | Vas-Cath, Inc. | 1991-04-09 | Traditional | PDF ↗ |
| K910995 | MEDI-TECH BALLOON DILATATION CATHETER | Boston Scientific Corp | 1991-04-09 | Traditional | PDF ↗ |
| K911203 | TEGWIRE (TM) | Boston Scientific Corp | 1991-04-09 | Traditional | PDF ↗ |
| K896520 | OWENS CATHETER | Boston Scientific Corp | 1991-03-25 | Traditional | PDF ↗ |
| K904410 | MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM) | Meadox Medicals, Div. Boston Scientific Corp. | 1991-03-25 | Traditional | PDF ↗ |
| K900677 | ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETER | Cook, Inc. | 1991-02-22 | Traditional | PDF ↗ |
| K910155 | SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH | Scimed Life Systems, Inc. | 1991-02-07 | Traditional | PDF ↗ |
| K905773 | PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER | Mallinckrodt Medical | 1991-01-30 | Traditional | PDF ↗ |
| K905250 | LOBOW | Perinatal Systems | 1991-01-08 | Traditional | PDF ↗ |
| K903417 | VAS-CATH OPTI-PLAST 5F PERIPHERAL ANGIOPLASTY CATH | Vas-Cath, Inc. | 1990-12-05 | Traditional | PDF ↗ |
| K902367 | OPTI-PLAST 7F PERIPHERAL ANGIOPLASTY CATHETER | Vas-Cath, Inc. | 1990-12-03 | Traditional | PDF ↗ |
| K902317 | PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATH. | Mallinckrodt Medical | 1990-12-03 | Traditional | PDF ↗ |
| K903582 | ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH. | Catheter Sciences Co. | 1990-11-06 | Traditional | PDF ↗ |
| K900094 | PE-MT 5 MEDI-TECH BALLOON DILATATION CATHETER | Boston Scientific Corp | 1990-10-31 | Traditional | PDF ↗ |
| K897106 | MEDI-TECH DILATATION CATHETERS ULTRA THIN II | Boston Scientific Corp | 1990-10-16 | Traditional | PDF ↗ |
| K903606 | GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER | North American Instrument Corp. | 1990-09-27 | Traditional | PDF ↗ |
| K902091 | SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER | Schneider Intl., Ltd. | 1990-09-26 | Traditional | PDF ↗ |
| K902454 | CATHSCANNER(R) PTA BALLOON DILATATION CATHETER | Endosonics Corp. | 1990-08-30 | Traditional | PDF ↗ |
| K897124 | SMALL VESSEL BALLOON DILATATION CATHETER | Boston Scientific Corp | 1990-07-17 | Traditional | PDF ↗ |
| K901601 | HOLLOW MOTOR DRIVE UNIT | Devices For Vascular Intervention, Inc. | 1990-07-06 | Traditional | PDF ↗ |
| K901767 | MODIFIED IVT PERIPHERAL ATHERECTOMY | Intensive Technology, Inc. | 1990-06-28 | Traditional | PDF ↗ |
| K901018 | MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS | Boston Scientific Corp | 1990-05-30 | Traditional | PDF ↗ |
| K894250 | LE PTA CATHETER | Baxter Healthcare Corp | 1990-03-07 | Traditional | PDF ↗ |
| K896403 | MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM | Intensive Technology, Inc. | 1990-03-06 | Traditional | PDF ↗ |
| K895179 | ACCESSOR PERIPHERAL DILATING GUIDE WIRE | Peripheral Systems Group | 1990-02-28 | Traditional | PDF ↗ |
| K894899 | EXPANSION OF THE CORDIS PTA DILATATION CATHETER | Cordis Corp. | 1990-01-26 | Traditional | PDF ↗ |
| K894944 | BALLOON DILATATION CATHETER | Peripheral Systems Group | 1990-01-19 | Traditional | PDF ↗ |
| K893411 | STEALTH DILATION CATHETER SYSTEM | Target Therapeutics | 1989-09-05 | Traditional | PDF ↗ |
| K890405 | USCI PTA BALLOON DILATATION CATHETER | C.R. Bard, Inc. | 1989-08-17 | Traditional | PDF ↗ |
| K890800 | ROTATING HEMOSTATIC VALVE | Datascope Corp. | 1989-06-12 | Traditional | PDF ↗ |
| K884327 | EXCEL Y-CONNECTOR CAT. #E-201 | Medical Profiles, Inc. | 1989-04-19 | Traditional | PDF ↗ |
| K890325 | USCI DISP. Y-CONNECTOR W/MODIFIED TUOHY-BORST ADAP | C.R. Bard, Inc. | 1989-03-15 | Traditional | PDF ↗ |
| K885247 | STANDARD, TUOHY BORST & DUAL VALVE Y-CONNECTOR | Baxter Healthcare Corp | 1989-03-10 | Traditional | PDF ↗ |
| K882826 | SOFTRAC-PTA PERIPHERAL DILATATION CATHETER | Schneider-Shilley (Usa) | 1989-01-24 | Traditional | PDF ↗ |
| K884481 | CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE | Mallinckroot, Inc. | 1989-01-10 | Traditional | PDF ↗ |
| K882925 | ACS SCHWARTEN XT BALLOON DILATATION CATHETER | Advanced Cardiovascular Systems, Inc. | 1988-09-28 | Traditional | PDF ↗ |
| K883346 | SIMPSON PERIPHERAL ATHEROCATH W/ADDIT. SIZE 13F | Devices For Vascular Intervention, Inc. | 1988-09-26 | Traditional | PDF ↗ |
| K882052 | OMEGA NV(TM) BALLOON DILATATION CATHETER | Cook, Inc. | 1988-09-14 | Traditional | PDF ↗ |
| K880612 | CORDIS PTA DILATATION CATHETERS | Cordis Corp. | 1988-07-28 | Traditional | PDF ↗ |
| K875175 | MODIFIED PERIPHERAL DILATATION CATHETERS | Schneider-Shilley (Usa) | 1988-07-28 | Traditional | PDF ↗ |
| K881088 | ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM) | Devices For Vascular Intervention, Inc. | 1988-05-31 | Traditional | PDF ↗ |
| K881197 | SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER | Schneider-Shilley (Usa) | 1988-05-16 | Traditional | PDF ↗ |
| K880298 | PERIPHERAL DILATATION CATHETER | Medi-Tech, Inc. | 1988-04-22 | Traditional | PDF ↗ |
| K880194 | KENSEY CATHETER | Theratek, Inc. | 1988-04-18 | Traditional | PDF ↗ |
| K880158 | ANGIOPLASTY BALLOON INFLATION DEVICE | L.O.N. Research, Inc. | 1988-03-22 | Traditional | PDF ↗ |
| K875064 | SCIMED INFLATION DEVICE, MODEL SM 2000 | Scimed Life Systems, Inc. | 1988-02-29 | Traditional | PDF ↗ |
| K874706 | MODIFIED SIMPSON PERIPHERAL ATHEROCATH | Devices For Vascular Intervention, Inc. | 1988-01-04 | Traditional | PDF ↗ |
| K871796 | NUMED PTA CATHETERS | NuMED, Inc. | 1987-12-03 | Traditional | PDF ↗ |
| K872542 | SCHNEIDER-SHILEY SOFTRAC-PTA(TM) ANGIO. CATHETER | Angiomedics, Inc. | 1987-09-14 | Traditional | PDF ↗ |
| K870215 | DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY) | Cook, Inc. | 1987-08-12 | Traditional | PDF ↗ |
| K871011 | SIMPSON PERIPHERAL ATHEROCATH(TM) | Devices For Vascular Intervention, Inc. | 1987-05-14 | Traditional | PDF ↗ |
| K862550 | OLBERT CATHETER SYSTEM WITH SIDEWINDER CURVE | Meadox Surgimed, Inc. | 1986-09-02 | Traditional | PDF ↗ |
| K862467 | SCHNEIDER-SHILEY SELDINGER INITIAL PUNCTURE INSTR | Shiley, Inc. | 1986-08-11 | Traditional | PDF ↗ |
| K854319 | SCHNEIDER-SHILEY PERIPHERAL DILATATION CATHETER | Shiley, Inc. | 1986-03-31 | Traditional | PDF ↗ |
| K853746 | ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO | Advanced Cardiovascular Systems, Inc. | 1985-10-21 | Traditional | PDF ↗ |
| K844913 | CORDIS PTA CATHETER-PERCUTANEOUS CATHETER | Cordis Corp. | 1985-08-20 | Traditional | PDF ↗ |
| K851854 | ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO | Advanced Cardiovascular Systems, Inc. | 1985-08-05 | Traditional | PDF ↗ |
| K851848 | PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETER | Mansfield Scientific, Inc. | 1985-07-19 | Traditional | PDF ↗ |
| K851080 | GV MEDICAL, INC. LASTAC BALLOON DILATATION CATHETE | G V Medical, Inc. | 1985-06-20 | Traditional | PDF ↗ |
| K844972 | ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER | Advanced Cardiovascular Systems, Inc. | 1985-05-16 | Traditional | PDF ↗ |
| K850075 | SCIMED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILAT | Scimed Life Systems, Inc. | 1985-04-10 | Traditional | PDF ↗ |
| K850760 | MILLS OPERATIVE PERIPHERAL ANGIOPLASTY CATHETER | Scimed Life Systems, Inc. | 1985-04-10 | Traditional | PDF ↗ |
| K843880 | LOW PROFILE STEERABLE BALLOON DILATION | Advanced Cardiovascular Systems, Inc. | 1984-11-27 | Traditional | PDF ↗ |
| K843383 | MEDI-TECH DILATATION CATHETERS | Medi-Tech, Inc. | 1984-10-24 | Traditional | PDF ↗ |
| K841961 | MILLS OPERATIVE PERIPHERAL ANGIOPLASTY | Scimed Life Systems, Inc. | 1984-10-23 | Traditional | PDF ↗ |
| K843501 | BALLOON DILATION CATHETER | Advanced Cardiovascular Systems, Inc. | 1984-10-04 | Traditional | PDF ↗ |
| K842556 | ADVANCED CARDIOVASCULAR BALLOON DILATA | Advanced Cardiovascular Systems, Inc. | 1984-08-10 | Traditional | PDF ↗ |
| K834429 | PERIPHERAL DILATATION ANGIOPLASTY-CATH | American Edwards Laboratories | 1984-08-10 | Traditional | PDF ↗ |
| K834220 | HYBRID PERIPHERAL DILATION CATHETER | American Edwards Laboratories | 1984-01-27 | Traditional | PDF ↗ |
| K833616 | OLBERT CATHETER SYSTEM | Meadox Medicals, Div. Boston Scientific Corp. | 1983-12-26 | Traditional | PDF ↗ |
| K833248 | LOW PROFILE STEERABLE-INTRAOPERATIVE | Advanced Cardiovascular Systems, Inc. | 1983-12-22 | Traditional | PDF ↗ |
| K832474 | FOGARTY-CHIN PERIPHERAL DILATION CATH | American Edwards Laboratories | 1983-09-29 | Traditional | PDF ↗ |
| K831659 | FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE | American Edwards Laboratories | 1983-08-12 | Traditional | PDF ↗ |
| K831403 | LOW PROFILE STEERABLE BALLOON DILATA | Advanced Cardiovascular Systems, Inc. | 1983-06-08 | Traditional | PDF ↗ |
| K830733 | FORGARTY CHIN PERIPHERAL INTRAOPERATIVE | American Edwards Laboratories | 1983-04-18 | Traditional | PDF ↗ |
Product code LIT · Class II · Cardiovascular. Data: openFDA.