Panels › Cardiovascular › Product code DWF · Class 2
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Regulation 870.4210
8510(k)s in 12 months (403 all time)
20recalls in 12 months (563 all time)
544recalls that name a 510(k)
Top companies in DWF
| Company | 510(k)s | Recalls |
|---|---|---|
| Maquet Cardiovascular | 0 | 184 |
| Terumo Cardiovascular Systems Corp. | 10 | 143 |
| Medtronic Perfusion Systems | 12 | 77 |
| Sorin Group USA, Inc. | 0 | 47 |
| Edwards Lifesciences | 19 | 21 |
| Medtronic, Inc. | 31 | 1 |
| Dlp, Inc. | 22 | 0 |
| 3M Health Care, Sarns | 21 | 0 |
| Shiley, Inc. | 21 | 0 |
| Edwards Lifesciences Research Medical | 4 | 13 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 17, 1984 | K834134 | SARNS 8.0 SOFT ARC CANNULA 3M Health Care, Sarns | DWF |
| Apr 12, 1984 | K833830 | 3-DAY BIOINDICATOR RELEASE PROCESS FOR Shiley, Inc. | DWF |
| Feb 13, 1984 | K840002 | ARTERIAL CANNULA CURVED BEVELED TIP Dlp, Inc. | DWF |
| Feb 13, 1984 | K840001 | ARTERIAL CANNULA STRAIGHT BEVELED TIP Dlp, Inc. | DWF |
| Jan 3, 1984 | K834039 | INFANT VENT CATHETER 12001 W/SIDE VENT Dlp, Inc. | DWF |
| Jan 3, 1984 | K834025 | SARNS CARDIOPLEGIA CANNULA Y 3M Health Care, Sarns | DWF |
| Nov 28, 1983 | K833112 | TUBING FOR CARDIOPULMONARY BYPASS Cardio Med Supplies, Inc. | DWF |
| Oct 19, 1983 | K832475 | AXIOM PERFUSSION CANNULA Axiom Medical, Inc. | DWF |
| Aug 12, 1983 | K832124 | CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI Med-West, Inc. | DWF |
| Aug 12, 1983 | K831769 | VARIOUS CARDIOVASCULAR SURGICAL DEVICE Research Industries Corp. | DWF |
| Aug 12, 1983 | K831759 | INTRACARDIA SUCKERS Research Industries Corp. | DWF |
| Aug 12, 1983 | K831130 | DISPOS. ABODOMINAL RETRACTING PAD Product Development Corp. | DWF |
| Aug 10, 1983 | K831330 | UNIVERSAL CORONARY CANNULA Possis Medical, Inc. | DWF |
| Jun 30, 1983 | K831591 | AORTIC ROOT CANNULA W/INTEGRAL PRESS Dlp, Inc. | DWF |
| Jun 30, 1983 | K831332 | ARGYLE DUAL STAGE VENOUS RETURN CATH. Sherwood Medical Co. | DWF |
| Apr 28, 1983 | K830728 | CARDIOVASCULAR DISPOSABLE PRODUCTS Electromics, Inc. | DWF |
| Aug 31, 1982 | K822317 | ARGYLE CAROTID ARTERY LOOP SHUNT Sherwood Medical Co. | DWF |
| Aug 24, 1982 | K822210 | SARNS CARDIOPLEGIA CANNULAE (VAR. TYPES 3M Health Care, Sarns | DWF |
| Aug 6, 1982 | K821316 | KONTRON LITWAK-KOFFSKY OBTURATED CANNU Kontron Instruments, Inc. | DWF |
| Jul 30, 1982 | K821445 | ARGYLE FERGUSON LEFT ATRIAL VENT CATH Sherwood Medical Co. | DWF |
| May 18, 1982 | K821149 | SUBMISSION CORONARY CANNULA Dlp, Inc. | DWF |
| Dec 14, 1981 | K813037 | FLOWGUARD CATHETERS & CANNALAE Advocacy International, Ltd. | DWF |
| Apr 23, 1981 | K810515 | DISPOSABLE 2-STAGE CANNULA Texas Medical Products, Inc. | DWF |
| Apr 3, 1981 | K810820 | CARDIOPULMONARY BYPASS Dlp, Inc. | DWF |
| Mar 17, 1981 | K810548 | CARDIOPULMINARY BYPASS CATHETER CANNULA Dlp, Inc. | DWF |
| Mar 17, 1981 | K810415 | SARNS TWO-STATE WIRE REINFORCED CATHETER 3M Health Care, Sarns | DWF |
| Jan 16, 1981 | K802543 | RIDGID VENA CAVA CANNULAE Texas Medical Products, Inc. | DWF |
| Oct 10, 1980 | K802378 | QUICK PRIME LINES, #'S BPL-12, BPL-48 & Bentley Laboratories, Inc. | DWF |
| Oct 3, 1980 | K802261 | PRESSURE GAUGE ACCESSORY KIT/DILATATION Stanco Medical, Inc. | DWF |
| Aug 7, 1980 | K801770 | ARTERIAL BUBBLE TRAP Delta Medical Industries | DWF |
| Jul 28, 1980 | K801359 | PRUITT VASCULAR SHUNT Ideas For Medicine, Inc. | DWF |
| Jun 30, 1980 | K801403 | DISPOSABLE PERFUSION SET Texas Medical Products, Inc. | DWF |
| Jun 30, 1980 | K801401 | CARDIOPULMONARY BYPASS TUBING Texas Medical Products, Inc. | DWF |
| Jun 30, 1980 | K801398 | AORTIC AND FEMORAL PERFUSION CANNULAE Texas Medical Products, Inc. | DWF |
| Jun 30, 1980 | K801397 | VENA CAVA CANNULAE Texas Medical Products, Inc. | DWF |
| Jun 30, 1980 | K801396 | SAPHENOUS VEIN CANNULAE Texas Medical Products, Inc. | DWF |
| Jun 30, 1980 | K801392 | DISPOSABLE SUMP SETS Texas Medical Products, Inc. | DWF |
| Nov 21, 1979 | K792070 | SARNS MEDIASTINAL AND PERICARDIAL TUBE 3M Health Care, Sarns | DWF |
| Nov 20, 1979 | K792202 | TROCAR CATHETER/THORACIC CATHETER Portex, Inc. | DWF |
| Nov 13, 1979 | K792152 | CARDIOPLEGIA SOLUTION ADMIN. SET Cardio Systems, Inc. | DWF |
| Nov 13, 1979 | K791947 | SHILEY CARDIOPLEGIC SOLUTION DEL SETS Shiley, Inc. | DWF |
| Oct 26, 1979 | K791858 | CARDIOPLEGIA ADMIN. SETS Travenol Laboratories, S.A. | DWF |
| Oct 11, 1979 | K791972 | ARGYLE PEDIATRIC VENA CAVAL CATHETER Sherwood Medical Co. | DWF |
| Oct 4, 1979 | K791832 | VEIN GRAFT CANNULA D/P, Inc. | DWF |
| Jun 11, 1979 | K790565 | AORTIC ROOT CANNULA Dlp, Inc. | DWF |
| Mar 2, 1979 | K790246 | SARNS WIRE-REINFORCED VENOUS RETURN CAN 3M Health Care, Sarns | DWF |
| Dec 4, 1978 | K781990 | CARDIAC INSULATION PAD Shiley, Inc. | DWF |
| Oct 4, 1977 | K771692 | TUBING SETS Cobe Laboratories, Inc. | DWF |
| Aug 16, 1977 | K771499 | FLEXIBLE ARTERIAL CANNULAE 3M Health Care, Sarns | DWF |
| Mar 16, 1977 | K770431 | CATHETER, TWO STAGE VENOUS RETURN 3M Health Care, Sarns | DWF |
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