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 |
|---|---|---|---|
| Aug 22, 1997 | K972665 | CHASE BLOOD VESSEL SHUNT Chase Medical, Inc. | DWF |
| Aug 12, 1997 | K971021 | CHASE PHRENIC NERVE PAD Chase Medical, Inc. | DWF |
| Jul 21, 1997 | K971019 | CHASE VESSEL CANNULA Chase Medical, Inc. | DWF |
| Jun 18, 1997 | K964374 | SARNS VENOUS RETURN CATHETERS WITH DURAFLO TREATMENT 3M Healthcare | DWF |
| Jun 18, 1997 | K964373 | SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT 3M Healthcare | DWF |
| Jun 17, 1997 | K971291 | HEARTPORT ENDOARTERIAL RETURN CANNULA Heartport, Inc. | DWF |
| May 13, 1997 | K971041 | CHASE CORONARY OSTIAL PERFUSION CANNULA Chase Medical, Inc. | DWF |
| May 13, 1997 | K970914 | CHASE AORTIC PERFUSION CANNULA Chase Medical, Inc. | DWF |
| May 13, 1997 | K964391 | CHASE LEFT VENT SAFETY VALVE Chase Medical, Inc. | DWF |
| Apr 23, 1997 | K964393 | CHASE RETROGRADE CARDIOPLEGIA CANNULA Chase Medical, Inc. | DWF |
| Apr 16, 1997 | K964200 | CHASE MULTIPLE PERFUSION SET Chase Medical, Inc. | DWF |
| Apr 16, 1997 | K964194 | CHASE CURVED LEFT HEART VENT CATHETER Chase Medical, Inc. | DWF |
| Apr 16, 1997 | K964193 | CHASE AORTIC ARCH CANNULA Chase Medical, Inc. | DWF |
| Mar 19, 1997 | K964199 | CHASE CORONARY SINUS PERFUSION CANNULA Chase Medical, Inc. | DWF |
| Mar 19, 1997 | K964198 | CAHSE AORTIC ROOT CANNULA Chase Medical, Inc. | DWF |
| Mar 19, 1997 | K964195 | CHASE TWO STAGE VENOUS RETURN CATHETER Chase Medical, Inc. | DWF |
| Feb 10, 1997 | K962835 | HEARTPORT ENDOVENOUS DRAINAGE CANNULA Heartport, Inc. | DWF |
| Jan 22, 1997 | K964248 | HEARTPORT ENDOCORONARY SINUS CATHETR Heartport, Inc. | DWF |
| Sep 5, 1996 | K961594 | BETTER-VENTER Circulatory Technology, Inc. | DWF |
| Aug 13, 1996 | K961927 | RMI HEMOCONCENTRACTOR TUBING SET Research Medical, Inc. | DWF |
| Jul 18, 1996 | K961717 | NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS Naltiac Medical, Inc. | DWF |
| Jun 21, 1996 | K961180 | NMI ANTEGRAD CARDIOPLEGIA CANNULA Naltiac Medical, Inc. | DWF |
| Jun 18, 1996 | K961270 | HEARTPORT ENDOSINUS CATHETER Heartport, Inc. | DWF |
| Jun 18, 1996 | K961245 | HEARTPORT ENDOPULMONARY VENT Heartport, Inc. | DWF |
| May 10, 1996 | K955121 | HEARTPORT ENDOARTERIAL RETURN CANNUAL Heartport, Inc. | DWF |
| Mar 26, 1996 | K955818 | FOAMSEAL RETROGRADE CARDIOPLEGIA CATHETER Quest Medical, Inc. | DWF |
| Mar 26, 1996 | K953945 | RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET Dlp, Inc. | DWF |
| Jun 14, 1995 | K951088 | QUEST RETROGRADE CARDIPLEGIA CANNULA-RCCS Quest Medical, Inc. | DWF |
| Jun 2, 1995 | K943934 | AORTIC ARCH CANNULAS Sorin Group Italia S.R.L., IT | DWF |
| May 25, 1995 | K950814 | QUEST ANTEGRADE CARDIOPLEGIA CANNULA Quest Medical, Inc. | DWF |
| Apr 6, 1995 | K941916 | QUEST CORONARY SINUS PERFUSION CANNULA -FRCC Quest Medical, Inc. | DWF |
| Jan 17, 1995 | K941166 | QUEST CORONARY SINUS PERFUSION CANNULA Quest Medical, Inc. | DWF |
| Aug 9, 1994 | K932208 | EXTRACORPOREAL CIRCUIT W/DURAFLO II HEPARIN TREATM Baxter Healthcare Corp | DWF |
| Feb 22, 1994 | K934127 | SARNS LOW JETTING AORTIC ARCH CANNULA 3M Health Care, Sarns | DWF |
| Feb 1, 1994 | K925049 | QUEST HEART INSULATION PAD Quest Medical, Inc. | DWF |
| Sep 27, 1993 | K931586 | VITAL-PORT MINI VASCULAR ACCESS SYSTEM Med Institute, Inc. | DWF |
| Jun 23, 1993 | K924529 | SIGNATURE(TM) CUSTOM TUBING PACK Avecor Cardiovascular, Inc. | DWF |
| May 21, 1993 | K925442 | SARNS RETROGRADE CANNULA 3M Health Care, Sarns | DWF |
| May 11, 1993 | K930684 | BARD WILLIAM HARVEY TWO STAGE CANNULA C.R. Bard, Inc. | DWF |
| May 11, 1993 | K920902 | MODIFICATION OF SARNS TWO STAGE VENOUS CANNULA 3M Health Care, Sarns | DWF |
| May 7, 1993 | K930620 | BARD(R) WILLIAM HARVEY(R) ARTERIAL STRAIGH CANNULA C.R. Bard, Inc. | DWF |
| May 6, 1993 | K930593 | BARD WILLIAM HARVEY AORTIC ROOT CARDIOPLEGIA CANNU C.R. Bard, Inc. | DWF |
| Mar 26, 1993 | K924642 | MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER Medtronic Bio-Medicus, Inc. | DWF |
| Mar 22, 1993 | K923483 | BARD WILLIAM HARVEY AORTIC ARCH CANULAE C.R. Bard, Inc. | DWF |
| Mar 12, 1993 | K922471 | SARNS RETROGRADE CANNULA - AUTO INFLATE 3M Health Care, Sarns | DWF |
| Dec 8, 1992 | K924643 | MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT Medtronic Bio-Medicus, Inc. | DWF |
| Sep 18, 1992 | K922992 | CONDUCER CARDIOPLEGIA SET SITH MP4 3M Health Care, Ltd. | DWF |
| Jul 27, 1992 | K915268 | CATHETER TWO STAGE VENOUS RETURN Dlp, Inc. | DWF |
| Mar 4, 1992 | K915193 | SARNS RETROGRADE CANNULA 3M Health Care, Sarns | DWF |
| Sep 19, 1991 | K910004 | FURUI SHUNT, 2-WAY AND 3-WAY Theramed, Inc. | DWF |
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