FDA 510(k) Applications for Medical Device Product Code "KFM"
(Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)

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


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