Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
FDA product code KFM · 84 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.4360
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1977-11-17 – 2025-08-04
KFM
2025-08-04
KFM
2025-06-24
Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)
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KFM
2023-10-26
Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)
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KFM
2023-08-03
LifeSPARC System
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KFM
2023-05-19
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
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KFM
2021-11-18
Capiox iCP Centrifugal Pump
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KFM
2021-11-03
Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
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KFM
2021-03-10
FloPump 57mL Centrifugal Pump
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KFM
2020-09-02
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
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KFM
2020-05-21
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface
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KFM
2020-04-13
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
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KFM
2019-08-27
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
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KFM
2019-08-07
Revolution Centrifugal Blood Pump
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KFM
2019-07-09
LifeSPARC Pump, LifeSPARC Controller
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KFM
2017-12-15
FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile
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KFM
2013-11-19
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER
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KFM
2013-11-12
QUADROX-IR ADULT AND SMALL ADULT
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KFM
2011-12-09
SARN CENTRIFUGAL PUMP
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KFM
2011-09-20
TANDEMHEART PUMP
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KFM
2011-07-27
AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF
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KFM
2011-06-28
AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE
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KFM
2011-06-23
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE
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KFM
2011-05-24
LIFEBRIDGE
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KFM
2011-04-27
IMPELLA CONTROLLER WITH FLOW CONTROL
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KFM
2010-12-27
LIFEBRIDGE
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KFM
2010-07-08
IMPELLA CONTROLLER
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KFM
2010-06-22
AFFIITY CP CENTRIFUGAL BLOOD PUMP
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KFM
2009-12-18
ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)
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KFM
2009-10-08
LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052
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KFM
2009-04-21
MECC SET WITH BIOLINE COATING
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KFM
2009-04-16
IMPELLA 5.0 CATHETER FAMILY
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KFM
2009-02-13
TERUMO ROCSAFE HYBRID PERFUSION SYSTEM
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KFM
2008-09-12
ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32
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KFM
2008-06-27
ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100
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KFM
2008-05-30
IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM
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KFM
2008-04-17
CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)
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KFM
2006-05-23
ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32
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KFM
2005-09-08
LEVITRONIX CENTRIMAG BACK-UP CONSOLE
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KFM
2005-05-05
ECC.O SYSTEM
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KFM
2005-02-11
TRILLIUM BIOPUMP PLUS, MODEL BPX80T
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KFM
2004-02-13
NOVOSCI READY SYSTEM, MODEL RS-200
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KFM
2003-07-09
IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
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KFM
2003-05-14
IBC FLOPUMP WITH GBS COATING
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KFM
2003-03-31
IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
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KFM
2003-03-25
LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100
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KFM
2003-03-06
COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
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KFM
2002-12-17
JOSTRA MECC SYSTEM
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KFM
2002-08-26
LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2
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KFM
2002-04-09
CARDIOVENTION CORX SYSTEM, MODEL FG 0001
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KFM
2002-04-04
SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
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KFM
2002-02-12
COBE REVOLUTION
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KFM
2001-11-09
HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H
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KFM
2001-08-15
CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X
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KFM
2000-11-01
AB-180 XC SYSTEM, MODEL AB-180XC
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KFM
2000-08-31
ROTAFLOW CENTRIFUGAL PUMP SYSTEM
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KFM
2000-05-04
A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000
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KFM
1999-03-24
IBC FLOPUMP, MODEL 6000
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KFM
1998-02-25
BPX80 BIO-PUMP (BPX80)
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KFM
1998-02-06
HIMEX CENTRIFLOW CENTRIFUGAL PERFUSION PUMP SYSTEM (CFK01)
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KFM
1997-02-25
CAPIOX SP PUMP HEAD
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KFM
1996-04-22
SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT
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KFM
1995-08-15
CAPIOX SP PUMP HEAD
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KFM
1994-09-28
LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI
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KFM
1993-09-09
SARNS 8000 DELPHIN II CENTRI PUMP MOD W/INTEGR BAT
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KFM
1993-07-28
SARNS 7850 CENTRIFUGAL PUMP (MODIFIED)
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KFM
1992-05-21
LIFESTREAM CENTRIFUGAL PUMP SYSTEM MODEL 2100CP
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KFM
1991-11-07
DELPHIN II CENTRIFUGAL SYSTEM
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KFM
1991-10-28
SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF
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KFM
1990-12-21
ARIES MELDICAL MODEL 2100HC HANK CRANK
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KFM
1990-12-17
SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW
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KFM
1990-07-13
SARNS DELPHIN BASE ADAPTER WITH BATTERY
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KFM
1990-03-28
SARNS DELPHIN BASE ADAPTER WITH MINI-BATTERY
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KFM
1989-09-26
ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP
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KFM
1989-01-24
SARNS 9000 WITH CENTRIFUGAL PUMP OPTION
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KFM
1988-11-03
SYMBION CENTRIFUGAL BLOOD PUMP MODEL I
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KFM
1988-10-13
CENTRIFUGAL PUMP SYSTEM LX/DX VERSION
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KFM
1986-01-15
ELECATH PULSATILE PERFUSION PUMP
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KFM
1985-09-30
BIO MEDICUS BIO PUMP MODEL BP-50
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KFM
1985-09-30
BIO MEDICUS BIO PUMP MODEL BP-80
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KFM
1985-06-19
BIO MEDICUS BIO PUMP MODEL BP-90
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KFM
1985-06-19
CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTER
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KFM
1984-08-03
CENTRIMED SYSTEM 1
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KFM
1978-08-31
MODEL 1861 BLOOD PUMP
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KFM
1977-11-17
PUMP, BYPASS, PULSATILE, AVCO
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