FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K992592 |
A-MED SYSTEMS, INC. |
A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000 |
05/04/2000 |
K013393 |
A-MED SYSTEMS, INC. |
HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H |
11/09/2001 |
K020529 |
A-MED SYSTEMS, INC. |
LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2 |
08/26/2002 |
K083111 |
ABIOMED, INC. |
IMPELLA 5.0 CATHETER FAMILY |
04/16/2009 |
K093801 |
ABIOMED, INC. |
IMPELLA CONTROLLER |
07/08/2010 |
K110845 |
ABIOMED, INC. |
IMPELLA CONTROLLER WITH FLOW CONTROL |
04/27/2011 |
K063723 |
ABIOMED, INC. |
IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM |
05/30/2008 |
K952879 |
BAXTER HEALTHCARE CORP. |
SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT |
04/22/1996 |
K991783 |
CARDIAC ASSIST, INC. |
AB-180 XC SYSTEM, MODEL AB-180XC |
11/01/2000 |
K183623 |
CardiacAssist Inc |
LifeSPARC Pump, LifeSPARC Controller |
07/09/2019 |
K110493 |
CARDIACASSIST INC. |
TANDEMHEART PUMP |
09/20/2011 |
K232132 |
CardiacAssist, Inc. |
LifeSPARC System |
08/03/2023 |
K012325 |
CARDIOVENTION, INC. |
CARDIOVENTION CORX SYSTEM, MODEL FG 0001 |
04/09/2002 |
K011835 |
COBE CARDIOVASCULAR, INC. |
COBE REVOLUTION |
02/12/2002 |
K030462 |
COBE CARDIOVASCULAR, INC. |
COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 |
03/06/2003 |
K032040 |
DIDECO S.P.A. |
IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR |
07/09/2003 |
K030154 |
DIDECO S.P.A. |
IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR |
03/31/2003 |
K050890 |
DIDECO S.R.L. |
ECC.O SYSTEM |
05/05/2005 |
K031300 |
GISH BIOMEDICAL, INC. |
IBC FLOPUMP WITH GBS COATING |
05/14/2003 |
K972740 |
HIMEX PRODUCTION CORP. |
HIMEX CENTRIFLOW CENTRIFUGAL PERFUSION PUMP SYSTEM (CFK01) |
02/06/1998 |
K983272 |
INTERNATIONAL BIOPHYSICS CORP. |
IBC FLOPUMP, MODEL 6000 |
03/24/1999 |
K170029 |
INTERNATIONAL BIOPHYSICS CORPORATION |
FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile |
12/15/2017 |
K193663 |
International Biophysics Corporation |
FloPump 57mL Centrifugal Pump |
03/10/2021 |
K023132 |
JOSTRA AG |
JOSTRA MECC SYSTEM |
12/17/2002 |
K991864 |
JOSTRA MEDIZINTECHNIK AG |
ROTAFLOW CENTRIFUGAL PUMP SYSTEM |
08/31/2000 |
K051209 |
LEVITRONIX LLC. |
LEVITRONIX CENTRIMAG BACK-UP CONSOLE |
09/08/2005 |
K020271 |
LEVITRONIX LLC. |
LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 |
03/25/2003 |
K090051 |
LEVITRONIX LLC. |
LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 |
10/08/2009 |
K103357 |
LIFEBRIDGE MEDIZINTECHNIK AG |
LIFEBRIDGE |
12/27/2010 |
K111384 |
LIFEBRIDGE MEDIZINTECHNIK AG |
LIFEBRIDGE |
05/24/2011 |
K083794 |
MAQUET CARDIOPULMONARY AG |
MECC SET WITH BIOLINE COATING |
04/21/2009 |
K133265 |
MAQUET CARDIOPULMONARY AG |
QUADROX-IR ADULT AND SMALL ADULT |
11/12/2013 |
K080470 |
MAQUET CARDIOPULMONARY AG |
ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32 |
09/12/2008 |
K061072 |
MAQUET CARDIOPULMONARY AG |
ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32 |
05/23/2006 |
K090515 |
MAQUET CARDIOPULMONARY AG |
ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA) |
12/18/2009 |
K973011 |
MEDTRONIC BIO-MEDICUS, INC. |
BPX80 BIO-PUMP (BPX80) |
02/25/1998 |
K191077 |
Medtronic Inc |
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor |
08/27/2019 |
K100631 |
MEDTRONIC INC. |
AFFIITY CP CENTRIFUGAL BLOOD PUMP |
06/22/2010 |
K111658 |
MEDTRONIC INC. |
AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE |
06/28/2011 |
K132712 |
MEDTRONIC INC. |
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER |
11/19/2013 |
K111972 |
MEDTRONIC INC. |
AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF |
07/27/2011 |
K050109 |
MEDTRONIC PERFUSION SYSTEMS |
TRILLIUM BIOPUMP PLUS, MODEL BPX80T |
02/11/2005 |
K111657 |
MEDTRONIC, INC. |
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE |
06/23/2011 |
K201068 |
Medtronic, Inc. |
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface |
05/21/2020 |
K033270 |
NOVOSCI CORP. |
NOVOSCI READY SYSTEM, MODEL RS-200 |
02/13/2004 |
K073631 |
ORQIS MEDICAL CORPORATION |
ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100 |
06/27/2008 |
K202169 |
Qura S.r.l |
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 |
09/02/2020 |
K220842 |
Qura S.r.l. |
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors |
05/19/2023 |
K201320 |
Qura S.r.l. |
Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor |
11/03/2021 |
K192850 |
Qura S.r.l. |
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 |
04/13/2020 |
K190650 |
SORIN GROUP ITALIA S.R.L. |
Revolution Centrifugal Blood Pump |
08/07/2019 |
K112229 |
TERUMO CARDIOVASCULAR SYSTEMS |
SARN CENTRIFUGAL PUMP |
12/09/2011 |
K080774 |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
CAPIOX SP PUMP (WITH OR WITHOUT X-COATING) |
04/17/2008 |
K012209 |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X |
08/15/2001 |
K020998 |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X |
04/04/2002 |
K082321 |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
TERUMO ROCSAFE HYBRID PERFUSION SYSTEM |
02/13/2009 |
K200091 |
Terumo Cardiovascular Systems Corporation |
Capiox iCP Centrifugal Pump |
11/18/2021 |
K962981 |
TERUMO MEDICAL CORP. |
CAPIOX SP PUMP HEAD |
02/25/1997 |