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 3, 2002 | K022042 | MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC) Cardeon Corp. | DWF |
| Aug 23, 2002 | K020768 | 3T VESSEL CANNULAS 3t Medical Systems, LLC | DWF |
| Jul 29, 2002 | K022174 | MODIFICATION TO CARDEON AEGIS CATHETER Cardeon Corp. | DWF |
| Jun 24, 2002 | K013593 | CARDEON AEGIS CATHETER Cardeon Corp. | DWF |
| Apr 24, 2002 | K020515 | JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA Jostra AG | DWF |
| Apr 11, 2002 | K002578 | AXILLARY ACCESS ARTERIAL CANNULA Edwards Lifesciences, LLC | DWF |
| Mar 26, 2002 | K014303 | JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE Jostra AG | DWF |
| Feb 11, 2002 | K013944 | JOSTRA DUAL STAGE VENOUS RETURN CANNULAE Jostra AG | DWF |
| Dec 4, 2001 | K013013 | MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. Medtronic Cardiac Surgical Products | DWF |
| Nov 16, 2001 | K012774 | JOSTRA ARTERIAL PERFUSION CANNULAE Jostra AG | DWF |
| Nov 6, 2001 | K012617 | JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A... Jostra AG | DWF |
| Oct 26, 2001 | K001509 | STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE Cobe Cardiovascular, Inc. | DWF |
| Aug 23, 2001 | K012538 | TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE Medtronic Vascular | DWF |
| Jun 18, 2001 | K010974 | RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET Sorin Group Italia S.R.L., IT | DWF |
| Apr 4, 2001 | K010737 | SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924 Medtronic Cardiac Surgical Products | DWF |
| Mar 30, 2001 | K002019 | RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET Sorin Group Italia S.R.L., IT | DWF |
| Feb 7, 2001 | K000776 | MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP Medtronic Cardiac Surgical Products | DWF |
| Jan 29, 2001 | K002273 | STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE Stoeckert Instrumente | DWF |
| Jan 25, 2001 | K001961 | STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE Stoeckert Instrumente | DWF |
| Dec 21, 2000 | K003371 | PUMP TUBING WITH X-COATING Terumo Corp. | DWF |
| Oct 5, 2000 | K002857 | ELS CANNULA (KIT), MODEL M1210-88,M1510-88 Jostra AG | DWF |
| Sep 18, 2000 | K002366 | QUEST MPS BACK-UP SYSYEM Quest Medical, Inc. | DWF |
| Sep 7, 2000 | K000830 | CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE California Medical Laboratories, Inc. | DWF |
| Aug 10, 2000 | K001565 | STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB Edwards Lifesciences, LLC | DWF |
| Jul 7, 2000 | K001371 | CARDEON ASCENDING BALLOON CANNULA (ABC) Cardeon Corp. | DWF |
| Jun 14, 2000 | K994209 | STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP Cobe Cardiovascular, Inc. | DWF |
| Jun 7, 2000 | K992932 | CIPA (ADULTS) CIPI (INFANTS) Dmc Medical, Ltd. | DWF |
| May 5, 2000 | K994243 | DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP Heartport, Inc. | DWF |
| Apr 27, 2000 | K994171 | MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE Medtronic Cardiac Surgical Products | DWF |
| Apr 17, 2000 | K993677 | MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT Medtronic Vascular | DWF |
| Feb 10, 2000 | K000274 | EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE Medtronic Cardiac Surgical Products | DWF |
| Feb 8, 2000 | K993818 | ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE California Medical Laboratories, Inc. | DWF |
| Dec 28, 1999 | K991541 | A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44 A-Med Systems, Inc. | DWF |
| Oct 1, 1999 | K990396 | T-ANASTAFLO Edwards Lifesciences Research Medical | DWF |
| Sep 14, 1999 | K991066 | MADTRONIC DLP ARTERIAL CANNULAE Medtronic Vascular | DWF |
| Jul 28, 1999 | K983270 | VOYAGER QUAD CANNULA Cardiothoracic Systems, Inc. | DWF |
| Jul 2, 1999 | K991170 | RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014 Edwards Lifesciences Research Medical | DWF |
| Jun 11, 1999 | K983791 | PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA Edwards Lifesciences Research Medical | DWF |
| Apr 20, 1999 | K981995 | QUICKDRAW VENOUS CANNULA Heartport, Inc. | DWF |
| Mar 23, 1999 | K990772 | DIRECTFLOW ARTERIAL CANNULA Heartport, Inc. | DWF |
| Dec 1, 1998 | K974259 | VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE Edwards Lifesciences Research Medical | DWF |
| Sep 4, 1998 | K981009 | HEARTPORT ENDOPULMONARY VENT CATHETER Heartport, Inc. | DWF |
| Jul 28, 1998 | K981601 | CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER Sorin Group Italia S.R.L., IT | DWF |
| Jul 15, 1998 | K974736 | HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER Heartport, Inc. | DWF |
| Apr 8, 1998 | K964205 | BETTER-TUBING Circulatory Technology, Inc. | DWF |
| Mar 31, 1998 | K972993 | CHASE FEMORAL ACCESS CANNULATION SET Chase Medical, Inc. | DWF |
| Nov 6, 1997 | K971928 | QUEST VESSEL CATHETER Quest Medical, Inc. | DWF |
| Sep 15, 1997 | K972261 | RIVETTI-LEVINSON INSTRALUMINAL SHUNT Integra Neurocare, LLC | DWF |
| Sep 8, 1997 | K971023 | CHASE THORACIC CATHETER Chase Medical, Inc. | DWF |
| Aug 26, 1997 | K972503 | CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE Sorin Group Italia S.R.L., IT | DWF |
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