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DWF

401 FDA 510(k) clearances · Product code

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RecordFirmDate
STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO) (K082344)Sorin Group Deutschland GmbH2008-12-17
AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR (K081820)Avalon Laboratories, LLC2008-10-06
AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR (K081933)Avalon Laboratories, LLC2008-10-03
TANDEMHEART TRANSSEPTAL CANNULA- EF 72 (K082425)Cardiacassist, Inc.2008-09-18
THREE STAGE VENOUS RETURN CANNULA, MODEL 816460 (K080034)Terumo Cardiovascular Systems Corp.2008-06-17
JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE (K072172)Maquet Cardiopulmonary, AG2007-08-31
TENDERFLOW PERIATRIC ARTERIAL CANNULA (K063618)Terumo Cardiovascular Systems Corp.2007-03-13
TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA (K062597)Terumo Cardiovascular Systems Corp.2006-11-03
JOSTRA HLM TUBING SETS WITH SAFELINE COATING (K061832)Maquet Cardiopulmonary, AG2006-08-11
EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 (K061254)Medtronic Perfusion Systems2006-06-23
ESTECH AORTIC EASY FLOW CANNULA (K060101)Endoscopic Technologies, Inc.2006-05-10
TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 (K052570)Cardiacassist, Inc.2006-01-17
REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA (K052081)Estech, Inc.2005-12-16
BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT (K052524)Medtronic Perfusion Systems2005-11-22
MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C (K052372)Medtronic Perfusion Systems2005-09-22
INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C (K042984)Intervascular2005-02-18
SELECT 3D ARTERIAL CANNULA (K043179)Medtronic Perfusion Systems2005-02-08
CARDEON COBRA CATHETER (K042156)Cardeon Corp.2004-10-06
MICRO PRIME (K041650)Innovx Medical, Inc.2004-08-16
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE (K033463)Edwards Lifesciences, LLC2004-07-28
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE (K033464)Edwards Lifesciences, LLC2004-06-22
JMS BYPASS TUBE (K032977)Jms North America Corp.2004-05-25
PEDIATRIC AORTIC ROOT CANNULA (K040173)Medtronic Perfusion Systems2004-03-19
JOSTRA SUCKERS, MODEL JS (K020983)Jostra AG2004-01-30
SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011 (K034058)Medtronic Vascular2004-01-29
SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE (K033416)Medtronic Perfusion Systems2003-11-05
MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES (K033264)Medtronic Perfusion Systems2003-10-31
REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH (K032632)Estech, Inc.2003-10-22
DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM) (K032041)LeMaitre Vascular, Inc.2003-08-27
MC2X MULTI-STAGE VENOUS CANNULA (K031776)Medtronic Perfusion Systems2003-07-25
ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX (K031827)Medtronic Perfusion Systems2003-07-02
TS3 TUBING SET (K031151)Global Blood Resources, LLC2003-06-26
EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX, (K031518)Medtronic Vascular2003-05-22
EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE (K031037)Medtronic Perfusion Systems2003-05-13
CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON (K030231)Sorin Group Italia S.R.L.2003-04-18
RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE) (K030696)Medtronic Perfusion Systems2003-04-11
JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS (K020784)Jostra AG2003-01-09
MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES) (K022272)Medtronic Cardiac Surgical Products2003-01-08
ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106 (K024069)Medtronic Vascular2003-01-08
MODIFICATION TO CARDEON AEGIS CATHETER (K024058)Cardeon Corp.2002-12-30
CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER (K023880)ETHICON, Inc.2002-12-11
PEDIATRIC ARTERIAL CANNULA (K023251)Polystan A/S2002-12-04
CIRCUIT TUBINGS WITH X-COATING (K023056)Terumo Cardiovascular Systems Corp.2002-11-26
STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35 (K023622)Stockert Instrumente GmbH2002-11-21
STOCKERT CORONARY PERFUSION CANNULAE (K022280)Stockert Instrumente GmbH2002-10-11
STOCKERT V172-28 VENOUS FEMORAL CANNULA (K022321)Stockert Instrumente GmbH2002-10-09
JOSTRA VENT CATHETERS, MODELS LV & HKV (K022022)Jostra AG2002-09-11
AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101 (K020693)Embol-X, Inc.2002-09-05
MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC) (K022042)Cardeon Corp.2002-09-03
3T VESSEL CANNULAS (K020768)3t Medical Systems, LLC2002-08-23
MODIFICATION TO CARDEON AEGIS CATHETER (K022174)Cardeon Corp.2002-07-29
CARDEON AEGIS CATHETER (K013593)Cardeon Corp.2002-06-24
JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA (K020515)Jostra AG2002-04-24
AXILLARY ACCESS ARTERIAL CANNULA (K002578)Edwards Lifesciences, LLC2002-04-11
JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE (K014303)Jostra AG2002-03-26
JOSTRA DUAL STAGE VENOUS RETURN CANNULAE (K013944)Jostra AG2002-02-11
MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. (K013013)Medtronic Cardiac Surgical Products2001-12-04
JOSTRA ARTERIAL PERFUSION CANNULAE (K012774)Jostra AG2001-11-16
JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A... (K012617)Jostra AG2001-11-06
STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE (K001509)Cobe Cardiovascular, Inc.2001-10-26
TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE (K012538)Medtronic Vascular2001-08-23
RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET (K010974)Sorin Group Italia S.R.L.2001-06-18
SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924 (K010737)Medtronic Cardiac Surgical Products2001-04-04
RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET (K002019)Sorin Group Italia S.R.L.2001-03-30
MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP (K000776)Medtronic Cardiac Surgical Products2001-02-07
STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE (K002273)Stoeckert Instrumente2001-01-29
STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE (K001961)Stoeckert Instrumente2001-01-25
PUMP TUBING WITH X-COATING (K003371)Terumo Corp.2000-12-21
ELS CANNULA (KIT), MODEL M1210-88,M1510-88 (K002857)Jostra AG2000-10-05
QUEST MPS BACK-UP SYSYEM (K002366)Quest Medical, Inc.2000-09-18
CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE (K000830)California Medical Laboratories, Inc.2000-09-07
STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB (K001565)Edwards Lifesciences, LLC2000-08-10
CARDEON ASCENDING BALLOON CANNULA (ABC) (K001371)Cardeon Corp.2000-07-07
STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP (K994209)Cobe Cardiovascular, Inc.2000-06-14
CIPA (ADULTS) CIPI (INFANTS) (K992932)Dmc Medical, Ltd.2000-06-07
DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP (K994243)Heartport, Inc.2000-05-05
MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE (K994171)Medtronic Cardiac Surgical Products2000-04-27
MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT (K993677)Medtronic Vascular2000-04-17
EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE (K000274)Medtronic Cardiac Surgical Products2000-02-10
ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE (K993818)California Medical Laboratories, Inc.2000-02-08
A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44 (K991541)A-Med Systems, Inc.1999-12-28
T-ANASTAFLO (K990396)Edwards Lifesciences Research Medical1999-10-01
MADTRONIC DLP ARTERIAL CANNULAE (K991066)Medtronic Vascular1999-09-14
VOYAGER QUAD CANNULA (K983270)Cardiothoracic Systems, Inc.1999-07-28
RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014 (K991170)Edwards Lifesciences Research Medical1999-07-02
PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA (K983791)Edwards Lifesciences Research Medical1999-06-11
QUICKDRAW VENOUS CANNULA (K981995)Heartport, Inc.1999-04-20
DIRECTFLOW ARTERIAL CANNULA (K990772)Heartport, Inc.1999-03-23
VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE (K974259)Edwards Lifesciences Research Medical1998-12-01
HEARTPORT ENDOPULMONARY VENT CATHETER (K981009)Heartport, Inc.1998-09-04
CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER (K981601)Sorin Group Italia S.R.L.1998-07-28
HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER (K974736)Heartport, Inc.1998-07-15
BETTER-TUBING (K964205)Circulatory Technology, Inc.1998-04-08
CHASE FEMORAL ACCESS CANNULATION SET (K972993)Chase Medical, Inc.1998-03-31
QUEST VESSEL CATHETER (K971928)Quest Medical, Inc.1997-11-06
RIVETTI-LEVINSON INSTRALUMINAL SHUNT (K972261)Integra Neurocare, LLC1997-09-15
CHASE THORACIC CATHETER (K971023)Chase Medical, Inc.1997-09-08
CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE (K972503)Sorin Group Italia S.R.L.1997-08-26
CHASE BLOOD VESSEL SHUNT (K972665)Chase Medical, Inc.1997-08-22
CHASE PHRENIC NERVE PAD (K971021)Chase Medical, Inc.1997-08-12
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