FDA Product Code
FDA Product Code DWF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4210
510(k) Clearances — 403 records · page 4 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K872043 | CHURCHILL INTER-CARDIAC SUCKER | Churchill Corp. | 1987-09-30 | Traditional | PDF ↗ |
| K872788 | MODIFIED CAROTID SHUNT W/SPRING REINFORCED LUMEN | Uresil Corp. | 1987-09-25 | Traditional | PDF ↗ |
| K872762 | TORAY ANTHRON AORTA BYPASS TUBES | Toray Industries (America), Inc. | 1987-09-24 | Traditional | PDF ↗ |
| K872159 | DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIES | Shiley, Inc. | 1987-08-12 | Traditional | PDF ↗ |
| K871844 | ARGYLE VASCULAR BYPASS SET | Sherwood Medical Co. | 1987-08-03 | Traditional | PDF ↗ |
| K870819 | BUBBLE TRAP CAT. NO. B-180 | American Omni Medical, Inc. | 1987-06-08 | Traditional | PDF ↗ |
| K870421 | TDMAC-HEPARIN COATED RMI | Research Medical, Inc. | 1987-05-22 | Traditional | PDF ↗ |
| K870109 | RMI VENOUS DRAINAGE CANNULA | Research Medical, Inc. | 1987-03-16 | Traditional | PDF ↗ |
| K870507 | GRUNWALD BI-CAVAL & JONES BI-CAVAL CANNULA | Research Medical, Inc. | 1987-03-16 | Traditional | PDF ↗ |
| K863342 | SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER | Angiomedics, Inc. | 1987-03-03 | Traditional | PDF ↗ |
| K865079 | ASPIRATING NEEDLE, CATALOG CODE #12006 | Dlp, Inc. | 1987-03-03 | Traditional | PDF ↗ |
| K863740 | RMI FEMORAL VENOUS DRAINAGE CANNULA | Research Medical, Inc. | 1987-02-19 | Traditional | PDF ↗ |
| K863558 | URESIL CAROTID SHUNT | Uresil Corp. | 1986-11-24 | Traditional | PDF ↗ |
| K862190 | WALRUS: DOUBLE BALLOON SHUNTING CATHETER | Medical Parameters, Inc. | 1986-11-03 | Traditional | PDF ↗ |
| K862634 | TDMAC-HEPARIN COATED RMI CAROTID BY-PASS SHUNT | Research Medical, Inc. | 1986-10-31 | Traditional | PDF ↗ |
| K861790 | RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNT | Research Medical, Inc. | 1986-07-21 | Traditional | PDF ↗ |
| K860136 | BARD-PARKER CAROTID SHUNT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-06-25 | Traditional | PDF ↗ |
| K861310 | STOCKERT-SHILEY AORTIC ROOT CANNULAE | Shiley, Inc. | 1986-05-30 | Traditional | PDF ↗ |
| K861322 | RMI POROUS VENT PLUG | Research Medical, Inc. | 1986-05-30 | Traditional | PDF ↗ |
| K860743 | CAROTID BYPASS SHUNT WITH SAMPLING ARM | Clincal Instruments Corp. | 1986-05-28 | Traditional | PDF ↗ |
| K860497 | CAROTID BALLOON SHUNT | Imodex, Inc. | 1986-05-28 | Traditional | PDF ↗ |
| K860742 | CAROTID BYPASS SHUNT | Clincal Instruments Corp. | 1986-05-28 | Traditional | PDF ↗ |
| K861103 | CHEST DRAINAGE PACK, CDP-1000 | Gish Biomedical, Inc. | 1986-05-28 | Traditional | PDF ↗ |
| K861116 | TORAY ANTHRON BYPASS TUBES | Toray Industries (America), Inc. | 1986-05-28 | Traditional | PDF ↗ |
| K861496 | STOCKERT-SHILEY VENOUS CATH & AORTIC ARCH CANNULA | Shiley, Inc. | 1986-05-27 | Traditional | PDF ↗ |
| K861096 | CARDIOPULMONARY CANNULA TUBING | Bio Medicus, Inc. | 1986-05-21 | Traditional | PDF ↗ |
| K860988 | RMI CAROTID BY-PASS SHUNT | Research Medical, Inc. | 1986-05-21 | Traditional | PDF ↗ |
| K860149 | VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015 | Dlp, Inc. | 1986-03-31 | Traditional | PDF ↗ |
| K854487 | VENOUS RETURN CANNULA W/CUFF 91039 | Dlp, Inc. | 1986-02-10 | Traditional | PDF ↗ |
| K854640 | MODIFIED CORONARY CARDIOPLEGIA ADAPTOR | Shiley, Inc. | 1986-02-10 | Traditional | PDF ↗ |
| K853128 | SARNS EVACUPLEGE CATHETER | 3M Health Care, Sarns | 1985-10-17 | Traditional | PDF ↗ |
| K852984 | SHILEY CSD EXTENSION LINE WITH FILTER | Shiley, Inc. | 1985-10-11 | Traditional | PDF ↗ |
| K851323 | AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU | C.R. Bard, Inc. | 1985-08-12 | Traditional | PDF ↗ |
| K833047 | DOSIMETRIC RELEASE OF RAD. TUBING PAC | American Bentley | 1985-06-11 | Traditional | PDF ↗ |
| K850917 | ARGYLE GRIFFITH TDMAC HEPARINIZED VENO-VENOUS SHUN | Sherwood Medical Co. | 1985-05-21 | Traditional | PDF ↗ |
| K850925 | BLOOD TUBING(PVC) 201458 W/(TOTM) PLASTICIZER | American Bentley | 1985-05-21 | Traditional | PDF ↗ |
| K850385 | INTRACARDIAC SUMP 12010 | Dlp, Inc. | 1985-04-29 | Traditional | PDF ↗ |
| K845046 | PUL,MONARY ARTERY VENT CATHETER | Dlp, Inc. | 1985-04-03 | Traditional | PDF ↗ |
| K845045 | VENOUS RETURN CATHETER SS-1 | Dlp, Inc. | 1985-04-03 | Traditional | PDF ↗ |
| K850356 | PRUITT-VASCULAR SHUNTS | Ideas For Medicine, Inc. | 1985-02-27 | Traditional | PDF ↗ |
| K844138 | STOCKERT-SHILEY HANDHELD REMOTE CONTROL INTRACARDI | Shiley, Inc. | 1984-12-27 | Traditional | PDF ↗ |
| K844139 | STOCKERT-SHILEY INTRACARDIAC SUCKERS | Shiley, Inc. | 1984-12-27 | Traditional | PDF ↗ |
| K844137 | STOCKERT-SHILEY VENOUS CATHETER & AORTIC ARCH CANN | Shiley, Inc. | 1984-12-27 | Traditional | PDF ↗ |
| K844140 | STOCKERT-SHILEY ATRIAL LEFT VENTRICULAR VENT CATH | Shiley, Inc. | 1984-12-27 | Traditional | PDF ↗ |
| K843444 | ARGYLE SILICONE LEFT VENTRICULAR AND | Sherwood Medical Co. | 1984-10-18 | Traditional | PDF ↗ |
| K843542 | SHILEY CORONARY CARDIOPLEGIA ADAPTOR | Shiley, Inc. | 1984-10-18 | Traditional | PDF ↗ |
| K842889 | ARGYLE CUSTOM TUBING PACK | Sherwood Medical Co. | 1984-08-27 | Traditional | PDF ↗ |
| K842375 | VENOUS CANNULA W/BENT, TIP WIRE | Dlp, Inc. | 1984-08-10 | Traditional | PDF ↗ |
| K841482 | PRESSURE CATHETER PLACEMENT SET 50010 | Dlp, Inc. | 1984-06-11 | Traditional | PDF ↗ |
| K840914 | ARGYLE TAPERED VASCULAR SHUNT | Sherwood Medical Co. | 1984-04-17 | Traditional | PDF ↗ |
| K834134 | SARNS 8.0 SOFT ARC CANNULA | 3M Health Care, Sarns | 1984-04-17 | Traditional | PDF ↗ |
| K833830 | 3-DAY BIOINDICATOR RELEASE PROCESS FOR | Shiley, Inc. | 1984-04-12 | Traditional | PDF ↗ |
| K840001 | ARTERIAL CANNULA STRAIGHT BEVELED TIP | Dlp, Inc. | 1984-02-13 | Traditional | PDF ↗ |
| K840002 | ARTERIAL CANNULA CURVED BEVELED TIP | Dlp, Inc. | 1984-02-13 | Traditional | PDF ↗ |
| K834025 | SARNS CARDIOPLEGIA CANNULA Y | 3M Health Care, Sarns | 1984-01-03 | Traditional | PDF ↗ |
| K834039 | INFANT VENT CATHETER 12001 W/SIDE VENT | Dlp, Inc. | 1984-01-03 | Traditional | PDF ↗ |
| K833112 | TUBING FOR CARDIOPULMONARY BYPASS | Cardio Med Supplies, Inc. | 1983-11-28 | Traditional | PDF ↗ |
| K832475 | AXIOM PERFUSSION CANNULA | Axiom Medical, Inc. | 1983-10-19 | Traditional | PDF ↗ |
| K832124 | CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI | Med-West, Inc. | 1983-08-12 | Traditional | PDF ↗ |
| K831130 | DISPOS. ABODOMINAL RETRACTING PAD | Product Development Corp. | 1983-08-12 | Traditional | PDF ↗ |
| K831769 | VARIOUS CARDIOVASCULAR SURGICAL DEVICE | Research Industries Corp. | 1983-08-12 | Traditional | PDF ↗ |
| K831759 | INTRACARDIA SUCKERS | Research Industries Corp. | 1983-08-12 | Traditional | PDF ↗ |
| K831330 | UNIVERSAL CORONARY CANNULA | Possis Medical, Inc. | 1983-08-10 | Traditional | PDF ↗ |
| K831591 | AORTIC ROOT CANNULA W/INTEGRAL PRESS | Dlp, Inc. | 1983-06-30 | Traditional | PDF ↗ |
| K831332 | ARGYLE DUAL STAGE VENOUS RETURN CATH. | Sherwood Medical Co. | 1983-06-30 | Traditional | PDF ↗ |
| K830728 | CARDIOVASCULAR DISPOSABLE PRODUCTS | Electromics, Inc. | 1983-04-28 | Traditional | PDF ↗ |
| K822317 | ARGYLE CAROTID ARTERY LOOP SHUNT | Sherwood Medical Co. | 1982-08-31 | Traditional | PDF ↗ |
| K822210 | SARNS CARDIOPLEGIA CANNULAE (VAR. TYPES | 3M Health Care, Sarns | 1982-08-24 | Traditional | PDF ↗ |
| K821316 | KONTRON LITWAK-KOFFSKY OBTURATED CANNU | Kontron Instruments, Inc. | 1982-08-06 | Traditional | PDF ↗ |
| K821445 | ARGYLE FERGUSON LEFT ATRIAL VENT CATH | Sherwood Medical Co. | 1982-07-30 | Traditional | PDF ↗ |
| K821149 | SUBMISSION CORONARY CANNULA | Dlp, Inc. | 1982-05-18 | Traditional | PDF ↗ |
| K813037 | FLOWGUARD CATHETERS & CANNALAE | Advocacy International, Ltd. | 1981-12-14 | Traditional | PDF ↗ |
| K810515 | DISPOSABLE 2-STAGE CANNULA | Texas Medical Products, Inc. | 1981-04-23 | Traditional | PDF ↗ |
| K810820 | CARDIOPULMONARY BYPASS | Dlp, Inc. | 1981-04-03 | Traditional | PDF ↗ |
| K810548 | CARDIOPULMINARY BYPASS CATHETER CANNULA | Dlp, Inc. | 1981-03-17 | Traditional | PDF ↗ |
| K810415 | SARNS TWO-STATE WIRE REINFORCED CATHETER | 3M Health Care, Sarns | 1981-03-17 | Traditional | PDF ↗ |
| K802543 | RIDGID VENA CAVA CANNULAE | Texas Medical Products, Inc. | 1981-01-16 | Traditional | PDF ↗ |
| K802378 | QUICK PRIME LINES, #'S BPL-12, BPL-48 & | Bentley Laboratories, Inc. | 1980-10-10 | Traditional | PDF ↗ |
| K802261 | PRESSURE GAUGE ACCESSORY KIT/DILATATION | Stanco Medical, Inc. | 1980-10-03 | Traditional | PDF ↗ |
| K801770 | ARTERIAL BUBBLE TRAP | Delta Medical Industries | 1980-08-07 | Traditional | PDF ↗ |
| K801359 | PRUITT VASCULAR SHUNT | Ideas For Medicine, Inc. | 1980-07-28 | Traditional | PDF ↗ |
| K801397 | VENA CAVA CANNULAE | Texas Medical Products, Inc. | 1980-06-30 | Traditional | PDF ↗ |
| K801398 | AORTIC AND FEMORAL PERFUSION CANNULAE | Texas Medical Products, Inc. | 1980-06-30 | Traditional | PDF ↗ |
| K801396 | SAPHENOUS VEIN CANNULAE | Texas Medical Products, Inc. | 1980-06-30 | Traditional | PDF ↗ |
| K801401 | CARDIOPULMONARY BYPASS TUBING | Texas Medical Products, Inc. | 1980-06-30 | Traditional | PDF ↗ |
| K801403 | DISPOSABLE PERFUSION SET | Texas Medical Products, Inc. | 1980-06-30 | Traditional | PDF ↗ |
| K801392 | DISPOSABLE SUMP SETS | Texas Medical Products, Inc. | 1980-06-30 | Traditional | PDF ↗ |
| K792070 | SARNS MEDIASTINAL AND PERICARDIAL TUBE | 3M Health Care, Sarns | 1979-11-21 | Traditional | PDF ↗ |
| K792202 | TROCAR CATHETER/THORACIC CATHETER | Portex, Inc. | 1979-11-20 | Traditional | PDF ↗ |
| K792152 | CARDIOPLEGIA SOLUTION ADMIN. SET | Cardio Systems, Inc. | 1979-11-13 | Traditional | PDF ↗ |
| K791947 | SHILEY CARDIOPLEGIC SOLUTION DEL SETS | Shiley, Inc. | 1979-11-13 | Traditional | PDF ↗ |
| K791858 | CARDIOPLEGIA ADMIN. SETS | Travenol Laboratories, S.A. | 1979-10-26 | Traditional | PDF ↗ |
| K791972 | ARGYLE PEDIATRIC VENA CAVAL CATHETER | Sherwood Medical Co. | 1979-10-11 | Traditional | PDF ↗ |
| K791832 | VEIN GRAFT CANNULA | D/P, Inc. | 1979-10-04 | Traditional | PDF ↗ |
| K790565 | AORTIC ROOT CANNULA | Dlp, Inc. | 1979-06-11 | Traditional | PDF ↗ |
| K790246 | SARNS WIRE-REINFORCED VENOUS RETURN CAN | 3M Health Care, Sarns | 1979-03-02 | Traditional | PDF ↗ |
| K781990 | CARDIAC INSULATION PAD | Shiley, Inc. | 1978-12-04 | Traditional | PDF ↗ |
| K771692 | TUBING SETS | Cobe Laboratories, Inc. | 1977-10-04 | Traditional | PDF ↗ |
| K771499 | FLEXIBLE ARTERIAL CANNULAE | 3M Health Care, Sarns | 1977-08-16 | Traditional | PDF ↗ |
| K770431 | CATHETER, TWO STAGE VENOUS RETURN | 3M Health Care, Sarns | 1977-03-16 | Traditional | PDF ↗ |
Product code DWF · Class II · Cardiovascular. Data: openFDA.