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 |
|---|---|---|---|
| Sep 30, 1987 | K872043 | CHURCHILL INTER-CARDIAC SUCKER Churchill Corp. | DWF |
| Sep 25, 1987 | K872788 | MODIFIED CAROTID SHUNT W/SPRING REINFORCED LUMEN Uresil Corp. | DWF |
| Sep 24, 1987 | K872762 | TORAY ANTHRON AORTA BYPASS TUBES Toray Industries (America), Inc. | DWF |
| Aug 12, 1987 | K872159 | DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIES Shiley, Inc. | DWF |
| Aug 3, 1987 | K871844 | ARGYLE VASCULAR BYPASS SET Sherwood Medical Co. | DWF |
| Jun 8, 1987 | K870819 | BUBBLE TRAP CAT. NO. B-180 American Omni Medical, Inc. | DWF |
| May 22, 1987 | K870421 | TDMAC-HEPARIN COATED RMI Research Medical, Inc. | DWF |
| Mar 16, 1987 | K870507 | GRUNWALD BI-CAVAL & JONES BI-CAVAL CANNULA Research Medical, Inc. | DWF |
| Mar 16, 1987 | K870109 | RMI VENOUS DRAINAGE CANNULA Research Medical, Inc. | DWF |
| Mar 3, 1987 | K865079 | ASPIRATING NEEDLE, CATALOG CODE #12006 Dlp, Inc. | DWF |
| Mar 3, 1987 | K863342 | SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETER Angiomedics, Inc. | DWF |
| Feb 19, 1987 | K863740 | RMI FEMORAL VENOUS DRAINAGE CANNULA Research Medical, Inc. | DWF |
| Nov 24, 1986 | K863558 | URESIL CAROTID SHUNT Uresil Corp. | DWF |
| Nov 3, 1986 | K862190 | WALRUS: DOUBLE BALLOON SHUNTING CATHETER Medical Parameters, Inc. | DWF |
| Oct 31, 1986 | K862634 | TDMAC-HEPARIN COATED RMI CAROTID BY-PASS SHUNT Research Medical, Inc. | DWF |
| Jul 21, 1986 | K861790 | RMI BALLOON-OCCLUSIVE CAROTID BY-PASS SHUNT Research Medical, Inc. | DWF |
| Jun 25, 1986 | K860136 | BARD-PARKER CAROTID SHUNT Bd Becton Dickinson Vacutainer Systems Preanalytic | DWF |
| May 30, 1986 | K861322 | RMI POROUS VENT PLUG Research Medical, Inc. | DWF |
| May 30, 1986 | K861310 | STOCKERT-SHILEY AORTIC ROOT CANNULAE Shiley, Inc. | DWF |
| May 28, 1986 | K861116 | TORAY ANTHRON BYPASS TUBES Toray Industries (America), Inc. | DWF |
| May 28, 1986 | K861103 | CHEST DRAINAGE PACK, CDP-1000 Gish Biomedical, Inc. | DWF |
| May 28, 1986 | K860743 | CAROTID BYPASS SHUNT WITH SAMPLING ARM Clincal Instruments Corp. | DWF |
| May 28, 1986 | K860742 | CAROTID BYPASS SHUNT Clincal Instruments Corp. | DWF |
| May 28, 1986 | K860497 | CAROTID BALLOON SHUNT Imodex, Inc. | DWF |
| May 27, 1986 | K861496 | STOCKERT-SHILEY VENOUS CATH & AORTIC ARCH CANNULA Shiley, Inc. | DWF |
| May 21, 1986 | K861096 | CARDIOPULMONARY CANNULA TUBING Bio Medicus, Inc. | DWF |
| May 21, 1986 | K860988 | RMI CAROTID BY-PASS SHUNT Research Medical, Inc. | DWF |
| Mar 31, 1986 | K860149 | VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015 Dlp, Inc. | DWF |
| Feb 10, 1986 | K854640 | MODIFIED CORONARY CARDIOPLEGIA ADAPTOR Shiley, Inc. | DWF |
| Feb 10, 1986 | K854487 | VENOUS RETURN CANNULA W/CUFF 91039 Dlp, Inc. | DWF |
| Oct 17, 1985 | K853128 | SARNS EVACUPLEGE CATHETER 3M Health Care, Sarns | DWF |
| Oct 11, 1985 | K852984 | SHILEY CSD EXTENSION LINE WITH FILTER Shiley, Inc. | DWF |
| Aug 12, 1985 | K851323 | AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU C.R. Bard, Inc. | DWF |
| Jun 11, 1985 | K833047 | DOSIMETRIC RELEASE OF RAD. TUBING PAC American Bentley | DWF |
| May 21, 1985 | K850925 | BLOOD TUBING(PVC) 201458 W/(TOTM) PLASTICIZER American Bentley | DWF |
| May 21, 1985 | K850917 | ARGYLE GRIFFITH TDMAC HEPARINIZED VENO-VENOUS SHUN Sherwood Medical Co. | DWF |
| Apr 29, 1985 | K850385 | INTRACARDIAC SUMP 12010 Dlp, Inc. | DWF |
| Apr 3, 1985 | K845046 | PUL,MONARY ARTERY VENT CATHETER Dlp, Inc. | DWF |
| Apr 3, 1985 | K845045 | VENOUS RETURN CATHETER SS-1 Dlp, Inc. | DWF |
| Feb 27, 1985 | K850356 | PRUITT-VASCULAR SHUNTS Ideas For Medicine, Inc. | DWF |
| Dec 27, 1984 | K844140 | STOCKERT-SHILEY ATRIAL LEFT VENTRICULAR VENT CATH Shiley, Inc. | DWF |
| Dec 27, 1984 | K844139 | STOCKERT-SHILEY INTRACARDIAC SUCKERS Shiley, Inc. | DWF |
| Dec 27, 1984 | K844138 | STOCKERT-SHILEY HANDHELD REMOTE CONTROL INTRACARDI Shiley, Inc. | DWF |
| Dec 27, 1984 | K844137 | STOCKERT-SHILEY VENOUS CATHETER & AORTIC ARCH CANN Shiley, Inc. | DWF |
| Oct 18, 1984 | K843542 | SHILEY CORONARY CARDIOPLEGIA ADAPTOR Shiley, Inc. | DWF |
| Oct 18, 1984 | K843444 | ARGYLE SILICONE LEFT VENTRICULAR AND Sherwood Medical Co. | DWF |
| Aug 27, 1984 | K842889 | ARGYLE CUSTOM TUBING PACK Sherwood Medical Co. | DWF |
| Aug 10, 1984 | K842375 | VENOUS CANNULA W/BENT, TIP WIRE Dlp, Inc. | DWF |
| Jun 11, 1984 | K841482 | PRESSURE CATHETER PLACEMENT SET 50010 Dlp, Inc. | DWF |
| Apr 17, 1984 | K840914 | ARGYLE TAPERED VASCULAR SHUNT Sherwood Medical Co. | DWF |
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