FDA Product Code
FDA Product Code DWF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4210
510(k) Clearances — 403 records · page 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K081881 | GISH TUBING AND CONNECTORS WITH HA COATING | Gish Biomedical, Inc. | 2009-01-23 | Traditional | PDF ↗ |
| K083301 | X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SARNS MALLEABLE VENOUS AND DUAL STAGE RETURN CATHETERS | Terumo Cardiovascular Systems Corp. | 2008-12-18 | Special | PDF ↗ |
| K082344 | STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO) | Sorin Group Deutschland GmbH | 2008-12-17 | Traditional | PDF ↗ |
| K081820 | AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR | Avalon Laboratories, LLC | 2008-10-06 | Traditional | PDF ↗ |
| K081933 | AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR | Avalon Laboratories, LLC | 2008-10-03 | Traditional | PDF ↗ |
| K082425 | TANDEMHEART TRANSSEPTAL CANNULA- EF 72 | Cardiacassist, Inc. | 2008-09-18 | Special | PDF ↗ |
| K080034 | THREE STAGE VENOUS RETURN CANNULA, MODEL 816460 | Terumo Cardiovascular Systems Corp. | 2008-06-17 | Traditional | PDF ↗ |
| K072172 | JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE | Maquet Cardiopulmonary, AG | 2007-08-31 | Special | PDF ↗ |
| K063618 | TENDERFLOW PERIATRIC ARTERIAL CANNULA | Terumo Cardiovascular Systems Corp. | 2007-03-13 | Special | PDF ↗ |
| K062597 | TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA | Terumo Cardiovascular Systems Corp. | 2006-11-03 | Special | PDF ↗ |
| K061832 | JOSTRA HLM TUBING SETS WITH SAFELINE COATING | Maquet Cardiopulmonary, AG | 2006-08-11 | Traditional | PDF ↗ |
| K061254 | EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 | Medtronic Perfusion Systems | 2006-06-23 | Special | PDF ↗ |
| K060101 | ESTECH AORTIC EASY FLOW CANNULA | Endoscopic Technologies, Inc. | 2006-05-10 | Traditional | PDF ↗ |
| K052570 | TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 | Cardiacassist, Inc. | 2006-01-17 | Traditional | PDF ↗ |
| K052081 | REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA | Estech, Inc. | 2005-12-16 | Traditional | PDF ↗ |
| K052524 | BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT | Medtronic Perfusion Systems | 2005-11-22 | Special | PDF ↗ |
| K052372 | MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C | Medtronic Perfusion Systems | 2005-09-22 | Special | PDF ↗ |
| K042984 | INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C | Intervascular | 2005-02-18 | Traditional | PDF ↗ |
| K043179 | SELECT 3D ARTERIAL CANNULA | Medtronic Perfusion Systems | 2005-02-08 | Special | PDF ↗ |
| K042156 | CARDEON COBRA CATHETER | Cardeon Corp. | 2004-10-06 | Traditional | PDF ↗ |
| K041650 | MICRO PRIME | Innovx Medical, Inc. | 2004-08-16 | Traditional | PDF ↗ |
| K033463 | EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE | Edwards Lifesciences, LLC | 2004-07-28 | Traditional | PDF ↗ |
| K033464 | EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE | Edwards Lifesciences, LLC | 2004-06-22 | Traditional | PDF ↗ |
| K032977 | JMS BYPASS TUBE | Jms North America Corp. | 2004-05-25 | Traditional | PDF ↗ |
| K040173 | PEDIATRIC AORTIC ROOT CANNULA | Medtronic Perfusion Systems | 2004-03-19 | Special | PDF ↗ |
| K020983 | JOSTRA SUCKERS, MODEL JS | Jostra AG | 2004-01-30 | Traditional | PDF ↗ |
| K034058 | SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011 | Medtronic Vascular | 2004-01-29 | Special | PDF ↗ |
| K033416 | SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE | Medtronic Perfusion Systems | 2003-11-05 | Special | PDF ↗ |
| K033264 | MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES | Medtronic Perfusion Systems | 2003-10-31 | Special | PDF ↗ |
| K032632 | REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH | Estech, Inc. | 2003-10-22 | Abbreviated | PDF ↗ |
| K032041 | DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM) | LeMaitre Vascular, Inc. | 2003-08-27 | Traditional | PDF ↗ |
| K031776 | MC2X MULTI-STAGE VENOUS CANNULA | Medtronic Perfusion Systems | 2003-07-25 | Special | PDF ↗ |
| K031827 | ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX | Medtronic Perfusion Systems | 2003-07-02 | Special | PDF ↗ |
| K031151 | TS3 TUBING SET | Global Blood Resources, LLC | 2003-06-26 | Traditional | PDF ↗ |
| K031518 | EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX, | Medtronic Vascular | 2003-05-22 | Special | PDF ↗ |
| K031037 | EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE | Medtronic Perfusion Systems | 2003-05-13 | Special | PDF ↗ |
| K030231 | CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON | Sorin Group Italia S.R.L. | 2003-04-18 | Traditional | PDF ↗ |
| K030696 | RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE) | Medtronic Perfusion Systems | 2003-04-11 | Special | PDF ↗ |
| K020784 | JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS | Jostra AG | 2003-01-09 | Traditional | PDF ↗ |
| K024069 | ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106 | Medtronic Vascular | 2003-01-08 | Special | PDF ↗ |
| K022272 | MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES) | Medtronic Cardiac Surgical Products | 2003-01-08 | Traditional | PDF ↗ |
| K024058 | MODIFICATION TO CARDEON AEGIS CATHETER | Cardeon Corp. | 2002-12-30 | Special | PDF ↗ |
| K023880 | CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER | ETHICON, Inc. | 2002-12-11 | Special | PDF ↗ |
| K023251 | PEDIATRIC ARTERIAL CANNULA | Polystan A/S | 2002-12-04 | Traditional | PDF ↗ |
| K023056 | CIRCUIT TUBINGS WITH X-COATING | Terumo Cardiovascular Systems Corp. | 2002-11-26 | Traditional | PDF ↗ |
| K023622 | STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35 | Stockert Instrumente GmbH | 2002-11-21 | Abbreviated | PDF ↗ |
| K022280 | STOCKERT CORONARY PERFUSION CANNULAE | Stockert Instrumente GmbH | 2002-10-11 | Abbreviated | PDF ↗ |
| K022321 | STOCKERT V172-28 VENOUS FEMORAL CANNULA | Stockert Instrumente GmbH | 2002-10-09 | Traditional | PDF ↗ |
| K022022 | JOSTRA VENT CATHETERS, MODELS LV & HKV | Jostra AG | 2002-09-11 | Traditional | PDF ↗ |
| K020693 | AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101 | Embol-X, Inc. | 2002-09-05 | Traditional | PDF ↗ |
| K022042 | MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC) | Cardeon Corp. | 2002-09-03 | Traditional | PDF ↗ |
| K020768 | 3T VESSEL CANNULAS | 3t Medical Systems, LLC | 2002-08-23 | Traditional | PDF ↗ |
| K022174 | MODIFICATION TO CARDEON AEGIS CATHETER | Cardeon Corp. | 2002-07-29 | Special | PDF ↗ |
| K013593 | CARDEON AEGIS CATHETER | Cardeon Corp. | 2002-06-24 | Traditional | PDF ↗ |
| K020515 | JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA | Jostra AG | 2002-04-24 | Traditional | PDF ↗ |
| K002578 | AXILLARY ACCESS ARTERIAL CANNULA | Edwards Lifesciences, LLC | 2002-04-11 | Traditional | PDF ↗ |
| K014303 | JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE | Jostra AG | 2002-03-26 | Traditional | PDF ↗ |
| K013944 | JOSTRA DUAL STAGE VENOUS RETURN CANNULAE | Jostra AG | 2002-02-11 | Traditional | PDF ↗ |
| K013013 | MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. | Medtronic Cardiac Surgical Products | 2001-12-04 | Traditional | PDF ↗ |
| K012774 | JOSTRA ARTERIAL PERFUSION CANNULAE | Jostra AG | 2001-11-16 | Traditional | PDF ↗ |
| K012617 | JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A... | Jostra AG | 2001-11-06 | Traditional | PDF ↗ |
| K001509 | STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE | Cobe Cardiovascular, Inc. | 2001-10-26 | Abbreviated | PDF ↗ |
| K012538 | TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE | Medtronic Vascular | 2001-08-23 | Special | PDF ↗ |
| K010974 | RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET | Sorin Group Italia S.R.L. | 2001-06-18 | Traditional | PDF ↗ |
| K010737 | SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924 | Medtronic Cardiac Surgical Products | 2001-04-04 | Special | PDF ↗ |
| K002019 | RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET | Sorin Group Italia S.R.L. | 2001-03-30 | Traditional | PDF ↗ |
| K000776 | MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP | Medtronic Cardiac Surgical Products | 2001-02-07 | Traditional | PDF ↗ |
| K002273 | STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE | Stoeckert Instrumente | 2001-01-29 | Abbreviated | PDF ↗ |
| K001961 | STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE | Stoeckert Instrumente | 2001-01-25 | Abbreviated | PDF ↗ |
| K003371 | PUMP TUBING WITH X-COATING | Terumo Corp. | 2000-12-21 | Traditional | PDF ↗ |
| K002857 | ELS CANNULA (KIT), MODEL M1210-88,M1510-88 | Jostra AG | 2000-10-05 | Traditional | PDF ↗ |
| K002366 | QUEST MPS BACK-UP SYSYEM | Quest Medical, Inc. | 2000-09-18 | Traditional | PDF ↗ |
| K000830 | CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE | California Medical Laboratories, Inc. | 2000-09-07 | Traditional | PDF ↗ |
| K001565 | STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB | Edwards Lifesciences, LLC | 2000-08-10 | Traditional | PDF ↗ |
| K001371 | CARDEON ASCENDING BALLOON CANNULA (ABC) | Cardeon Corp. | 2000-07-07 | Traditional | PDF ↗ |
| K994209 | STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP | Cobe Cardiovascular, Inc. | 2000-06-14 | Abbreviated | PDF ↗ |
| K992932 | CIPA (ADULTS) CIPI (INFANTS) | Dmc Medical, Ltd. | 2000-06-07 | Traditional | PDF ↗ |
| K994243 | DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP | Heartport, Inc. | 2000-05-05 | Special | PDF ↗ |
| K994171 | MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE | Medtronic Cardiac Surgical Products | 2000-04-27 | Traditional | PDF ↗ |
| K993677 | MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT | Medtronic Vascular | 2000-04-17 | Traditional | PDF ↗ |
| K000274 | EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE | Medtronic Cardiac Surgical Products | 2000-02-10 | Special | PDF ↗ |
| K993818 | ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE | California Medical Laboratories, Inc. | 2000-02-08 | Traditional | PDF ↗ |
| 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. | 1999-12-28 | Traditional | PDF ↗ |
| K990396 | T-ANASTAFLO | Edwards Lifesciences Research Medical | 1999-10-01 | Traditional | PDF ↗ |
| K991066 | MADTRONIC DLP ARTERIAL CANNULAE | Medtronic Vascular | 1999-09-14 | Traditional | PDF ↗ |
| K983270 | VOYAGER QUAD CANNULA | Cardiothoracic Systems, Inc. | 1999-07-28 | Traditional | PDF ↗ |
| K991170 | RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014 | Edwards Lifesciences Research Medical | 1999-07-02 | Traditional | PDF ↗ |
| K983791 | PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA | Edwards Lifesciences Research Medical | 1999-06-11 | Traditional | PDF ↗ |
| K981995 | QUICKDRAW VENOUS CANNULA | Heartport, Inc. | 1999-04-20 | Traditional | PDF ↗ |
| K990772 | DIRECTFLOW ARTERIAL CANNULA | Heartport, Inc. | 1999-03-23 | Special | PDF ↗ |
| K974259 | VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE | Edwards Lifesciences Research Medical | 1998-12-01 | Traditional | PDF ↗ |
| K981009 | HEARTPORT ENDOPULMONARY VENT CATHETER | Heartport, Inc. | 1998-09-04 | Traditional | PDF ↗ |
| K981601 | CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER | Sorin Group Italia S.R.L. | 1998-07-28 | Traditional | PDF ↗ |
| K974736 | HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER | Heartport, Inc. | 1998-07-15 | Traditional | PDF ↗ |
| K964205 | BETTER-TUBING | Circulatory Technology, Inc. | 1998-04-08 | Traditional | PDF ↗ |
| K972993 | CHASE FEMORAL ACCESS CANNULATION SET | Chase Medical, Inc. | 1998-03-31 | Traditional | PDF ↗ |
| K971928 | QUEST VESSEL CATHETER | Quest Medical, Inc. | 1997-11-06 | Traditional | PDF ↗ |
| K972261 | RIVETTI-LEVINSON INSTRALUMINAL SHUNT | Integra Neurocare, LLC | 1997-09-15 | Traditional | PDF ↗ |
| K971023 | CHASE THORACIC CATHETER | Chase Medical, Inc. | 1997-09-08 | Traditional | PDF ↗ |
| K972503 | CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE | Sorin Group Italia S.R.L. | 1997-08-26 | Traditional | PDF ↗ |
Product code DWF · Class II · Cardiovascular. Data: openFDA.