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 |
|---|---|---|---|
| Jan 23, 2009 | K081881 | GISH TUBING AND CONNECTORS WITH HA COATING Gish Biomedical, Inc. | DWF |
| Dec 18, 2008 | K083301 | X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS Terumo Cardiovascular Systems Corp. | DWF |
| Dec 17, 2008 | K082344 | STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO) Sorin Group Deutschland GmbH | DWF |
| Oct 6, 2008 | K081820 | AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR Avalon Laboratories, LLC | DWF |
| Oct 3, 2008 | K081933 | AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR Avalon Laboratories, LLC | DWF |
| Sep 18, 2008 | K082425 | TANDEMHEART TRANSSEPTAL CANNULA- EF 72 Cardiacassist, Inc. | DWF |
| Jun 17, 2008 | K080034 | THREE STAGE VENOUS RETURN CANNULA, MODEL 816460 Terumo Cardiovascular Systems Corp. | DWF |
| Aug 31, 2007 | K072172 | JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE Maquet Cardiopulmonary, AG, DE | DWF |
| Mar 13, 2007 | K063618 | TENDERFLOW PERIATRIC ARTERIAL CANNULA Terumo Cardiovascular Systems Corp. | DWF |
| Nov 3, 2006 | K062597 | TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA Terumo Cardiovascular Systems Corp. | DWF |
| Aug 11, 2006 | K061832 | JOSTRA HLM TUBING SETS WITH SAFELINE COATING Maquet Cardiopulmonary, AG | DWF |
| Jun 23, 2006 | K061254 | EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 Medtronic Perfusion Systems | DWF |
| May 10, 2006 | K060101 | ESTECH AORTIC EASY FLOW CANNULA Endoscopic Technologies, Inc. | DWF |
| Jan 17, 2006 | K052570 | TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 Cardiacassist, Inc. | DWF |
| Dec 16, 2005 | K052081 | REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA Estech, Inc. | DWF |
| Nov 22, 2005 | K052524 | BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT Medtronic Perfusion Systems | DWF |
| Sep 22, 2005 | K052372 | MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C Medtronic Perfusion Systems | DWF |
| Feb 18, 2005 | K042984 | INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C Intervascular | DWF |
| Feb 8, 2005 | K043179 | SELECT 3D ARTERIAL CANNULA Medtronic Perfusion Systems | DWF |
| Oct 6, 2004 | K042156 | CARDEON COBRA CATHETER Cardeon Corp. | DWF |
| Aug 16, 2004 | K041650 | MICRO PRIME Innovx Medical, Inc. | DWF |
| Jul 28, 2004 | K033463 | EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE Edwards Lifesciences, LLC | DWF |
| Jun 22, 2004 | K033464 | EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE Edwards Lifesciences, LLC | DWF |
| May 25, 2004 | K032977 | JMS BYPASS TUBE Jms North America Corp. | DWF |
| Mar 19, 2004 | K040173 | PEDIATRIC AORTIC ROOT CANNULA Medtronic Perfusion Systems | DWF |
| Jan 30, 2004 | K020983 | JOSTRA SUCKERS, MODEL JS Jostra AG | DWF |
| Jan 29, 2004 | K034058 | SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011 Medtronic Vascular | DWF |
| Nov 5, 2003 | K033416 | SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE Medtronic Perfusion Systems | DWF |
| Oct 31, 2003 | K033264 | MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES Medtronic Perfusion Systems | DWF |
| Oct 22, 2003 | K032632 | REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH Estech, Inc. | DWF |
| Aug 27, 2003 | K032041 | DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM) LeMaitre Vascular, Inc. | DWF |
| Jul 25, 2003 | K031776 | MC2X MULTI-STAGE VENOUS CANNULA Medtronic Perfusion Systems | DWF |
| Jul 2, 2003 | K031827 | ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX Medtronic Perfusion Systems | DWF |
| Jun 26, 2003 | K031151 | TS3 TUBING SET Global Blood Resources, LLC | DWF |
| May 22, 2003 | K031518 | EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX, Medtronic Vascular | DWF |
| May 13, 2003 | K031037 | EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE Medtronic Perfusion Systems | DWF |
| Apr 18, 2003 | K030231 | CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON Sorin Group Italia S.R.L., IT | DWF |
| Apr 11, 2003 | K030696 | RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE) Medtronic Perfusion Systems | DWF |
| Jan 9, 2003 | K020784 | JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS Jostra AG | DWF |
| Jan 8, 2003 | K024069 | ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106 Medtronic Vascular | DWF |
| Jan 8, 2003 | K022272 | MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES) Medtronic Cardiac Surgical Products | DWF |
| Dec 30, 2002 | K024058 | MODIFICATION TO CARDEON AEGIS CATHETER Cardeon Corp. | DWF |
| Dec 11, 2002 | K023880 | CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER ETHICON, Inc. | DWF |
| Dec 4, 2002 | K023251 | PEDIATRIC ARTERIAL CANNULA Polystan A/S, DK | DWF |
| Nov 26, 2002 | K023056 | CIRCUIT TUBINGS WITH X-COATING Terumo Cardiovascular Systems Corp. | DWF |
| Nov 21, 2002 | K023622 | STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35 Stockert Instrumente GmbH | DWF |
| Oct 11, 2002 | K022280 | STOCKERT CORONARY PERFUSION CANNULAE Stockert Instrumente GmbH | DWF |
| Oct 9, 2002 | K022321 | STOCKERT V172-28 VENOUS FEMORAL CANNULA Stockert Instrumente GmbH | DWF |
| Sep 11, 2002 | K022022 | JOSTRA VENT CATHETERS, MODELS LV & HKV Jostra AG | DWF |
| Sep 5, 2002 | K020693 | AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101 Embol-X, Inc. | DWF |
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