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 |
|---|---|---|---|
| May 22, 1991 | K910021 | CARDIOPULMONARY BYPASS PUMP TUBING Jtl Medical Corp. | DWF |
| Feb 5, 1991 | K905224 | CARDIOPULMONARY BYPASS VASCULAR CATHETER 3M Health Care, Sarns | DWF |
| Feb 1, 1991 | K905638 | SARNS INVENT CATHETERS 3M Health Care, Sarns | DWF |
| Jan 15, 1991 | K905312 | DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS Baxter Bentley Laboratories, Inc. | DWF |
| Sep 27, 1990 | K902394 | RESUBMITTED MULTIORGAN PERFUSION CANNULA Fresenius USA, Inc. | DWF |
| Aug 14, 1990 | K902277 | BARD EXTRACORPOREAL CIRCULATION CANNULAE C.R. Bard, Inc. | DWF |
| Jul 6, 1990 | K901074 | CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA Dlp, Inc. | DWF |
| Jun 8, 1990 | K901231 | RMI CARDIOPLEGIA DELIVERY KITS Research Medical, Inc. | DWF |
| May 17, 1990 | K896338 | VOSS DISPOSABLE CORONARY BYPASS FLUSHING CANNULA Voss Medical Products | DWF |
| Apr 10, 1990 | K900753 | SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT) Shiley, Inc. | DWF |
| Mar 16, 1990 | K897022 | PICSO CANNULA, CATALOG CODE 94315 Dlp, Inc. | DWF |
| Feb 27, 1990 | K896778 | RMI VASOPLEGIA CANNULA WITH & WITHOUT CHECK VALVE Research Medical, Inc. | DWF |
| Feb 27, 1990 | K896777 | RMI AORTIC ROOT PRESSURE MONITOR EXTENSION LINE Research Medical, Inc. | DWF |
| Feb 26, 1990 | K897026 | CANYON MEDICAL FEMORAL BYPASS CANNULAE AND INTRO. Canyon Medical Products | DWF |
| Feb 15, 1990 | K896636 | RMI ANTEPLEGIA CANNULA Research Medical, Inc. | DWF |
| Nov 29, 1989 | K895352 | KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN Kendall Healthcare Products Co. Div.Of Tyco Health | DWF |
| Oct 17, 1989 | K894684 | PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT Pioneering Technologies, Inc. | DWF |
| Oct 12, 1989 | K891576 | FEM-FLEX FEMORAL ACCESS CANNULATION SET Research Medical, Inc. | DWF |
| May 1, 1989 | K890980 | MODIFIED STOCKERT-SHILEY VENOUS CATHETER Shiley, Inc. | DWF |
| Mar 2, 1989 | K890024 | SARNS VENT CATHETER 3M Company | DWF |
| Feb 8, 1989 | K883412 | THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM) Promedica Products, Inc. | DWF |
| Feb 6, 1989 | K885188 | MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY Quinton, Inc. | DWF |
| Jan 10, 1989 | K884310 | ANGIOPUMP TUBING SET Olympus Corp. | DWF |
| Dec 27, 1988 | K884393 | MODIFIED SHILEY FEMORAL ARTERIAL CANNULA Shiley, Inc. | DWF |
| Nov 3, 1988 | K883981 | GUIDING CATHETER (TIP SOFTNESS CHANGE) Devices For Vascular Intervention, Inc. | DWF |
| Oct 13, 1988 | K883221 | PTI INTRA-ART INTER MAMM ARTERY PAPAVER INFUS KIT Pioneering Technologies, Inc. | DWF |
| Sep 27, 1988 | K882771 | EXTRACORPOREAL MEMBRANE OXYGENATION CATHETER Cook, Inc. | DWF |
| Jul 28, 1988 | K882034 | INTRA-ART(TM) INTERNAL MAMMARY INFUSION CATHETER Buckman Co., Inc. | DWF |
| Jul 6, 1988 | K881733 | SHILEY FEMORAL CORONARY PERFUSION CATHETER Shiley, Inc. | DWF |
| Jul 5, 1988 | K881734 | SHILEY FEMORAL LEFT VENTRICULAR VENT CATHETER Shiley, Inc. | DWF |
| Jul 5, 1988 | K881691 | PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA Shiley, Inc. | DWF |
| Jun 10, 1988 | K881330 | COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK Cobe Laboratories, Inc. | DWF |
| Jun 9, 1988 | K881352 | RIGHT ATRIAL CATHETER INSERTION TRAY Quinton, Inc. | DWF |
| May 31, 1988 | K881074 | SHILEY FEMORAL VENOUS CANNULA Shiley, Inc. | DWF |
| May 31, 1988 | K881072 | SHILEY FEMORAL ARTERIAL CANNULA Shiley, Inc. | DWF |
| May 24, 1988 | K880887 | NEOCATH Taris Corp. | DWF |
| May 24, 1988 | K880777 | 8.5 FR. PESCUTANEOUS SHEATH INTRODUCER SYSTEM Medsurg Industries, Inc. | DWF |
| May 9, 1988 | K880779 | MEDSURG 16 GA. CENTRAL VEIN CATHETERIZATION TRAY Medsurg Industries, Inc. | DWF |
| Apr 28, 1988 | K880421 | DESCENDING ARCH CANNULA Dlp, Inc. | DWF |
| Mar 22, 1988 | K880180 | STATFLO Imodex, Inc. | DWF |
| Mar 22, 1988 | K880103 | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPUL. Research Medical, Inc. | DWF |
| Mar 22, 1988 | K875353 | PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT Dlp, Inc. | DWF |
| Feb 18, 1988 | K875048 | SARNS VENOATRIAL CATHETER 3M Health Care, Sarns | DWF |
| Feb 18, 1988 | K874899 | CANYON MEDICAL FEMORAL BYPASS CANNULAE Canyon Medical Products | DWF |
| Feb 5, 1988 | K874853 | POLYSTAN TWO STAGE CATHETERS Polystan C/O Vitalcor, Inc. | DWF |
| Feb 5, 1988 | K874852 | POLYSTAN WIRE REINFORCED TWO STAGE CATHETERS Polystan C/O Vitalcor, Inc. | DWF |
| Feb 2, 1988 | K874896 | SARNS VISIFLOW AORTIC ARCH CANNULA 3M Health Care, Sarns | DWF |
| Jan 19, 1988 | K874834 | ARGYLE CARDIOPLEGIA CANNULA Sherwood Medical Co. | DWF |
| Dec 7, 1987 | K872033 | BIO-MEDICUS CANNULA-TUBING Bio Medicus, Inc. | DWF |
| Nov 6, 1987 | K873212 | SARNS CARDIOPLEGIA/VENT CATHETERS 3M Health Care, Sarns | DWF |
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