Product Code: KFM


Products Classified as KFM

847Pump, Blood, Cardiopulmonary Bypass, Non-roller TypeNonroller-type Blood Pump.

Total Product Life Cycle (TPLC) Devices

847Pump, Blood, Cardiopulmonary Bypass, Non-roller TypeNonroller-type Blood Pump.

FDA Consensus Standards

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type [38112]21 CFR §870.4360 🔎
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type [38111]21 CFR §870.4360 🔎

Pre-market Notifications for KFM

K202169Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22Qura S.r.l
K201320Quantum PureFlow Centrifugal Blood Pump CP22 With Integrated SensorQura S.r.l.
K201068Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump With Balance Biosurface, Affinity CP Centrifugal Blood Pump With Cortiva BioActive SurfaceMedtronic, Inc.
K200091Capiox ICP Centrifugal PumpTerumo Cardiovascular Systems Corporation
K193663FloPump 57mL Centrifugal PumpInternational Biophysics Corporation
K192850Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22Qura S.r.l.
K191077Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump With Balance Biosurface, Affinity CP Centrifugal Blood Pump With Cortive BioActive Surface, Medtronic External Drive MotorMedtronic Inc
K190650Revolution Centrifugal Blood PumpSORIN GROUP ITALIA S.R.L.
K183623LifeSPARC Pump, LifeSPARC ControllerCardiacAssist Inc
K170029FloPump 32mL, Sterile, FloPump 32mL, Non-SterileINTERNATIONAL BIOPHYSICS CORPORATION
K133265QUADROX-IR ADULT AND SMALL ADULTMAQUET CARDIOPULMONARY AG
K132712AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTERMEDTRONIC INC.
K112229SARN CENTRIFUGAL PUMPTERUMO CARDIOVASCULAR SYSTEMS
K111972AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAFMEDTRONIC INC.
K111658AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACEMEDTRONIC INC.

Global Unique Device Identification Database

00613994952318PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
00613994951816PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
00613994950079PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
00613994947918PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
00613994946669PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
00613994934987PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
00613994934864PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
00613994933881PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
00613994932969PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
00613994930392PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
00613994929570PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
00613994923370PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
00613994921734PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
00613994917744PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
00613994917669PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Maude Adverse Events

CENTRIMAG MOTOR, USTHORATEC SWITZERLAND GMBH2020-03-31
HEART LUNG MACHINEMAQUET CARDIOPULMONARY GMBH2020-03-30
HEART-LUNG-MACHINEMAQUET CARDIOPULMONARY GMBH2020-03-30
CENTRIMAG MOTOR, USTHORATEC SWITZERLAND GMBH2020-03-30
HEART LUNG MACHINEMAQUET CARDIOPULMONARY GMBH2020-03-27
HEART LUNG MACHINE2020-03-27
TANDEMHEART PUMPCARDIACASSIST INC.2020-03-25
HEART LUNG MACHINEMAQUET CARDIOPULMONARY GMBH2020-03-24
CENTRIMAG MOTOR, USTHORATEC SWITZERLAND GMBH2020-03-24
CENTRIMAG MOTOR, USTHORATEC SWITZERLAND GMBH2020-03-24
HEART LUNG MACHINEMAQUET CARDIOPULMONARY GMBH2020-03-23
HEART LUNG MACHINEMAQUET CARDIOPULMONARY GMBH2020-03-23
HEART LUNG MACHINEMAQUET CARDIOPULMONARY GMBH2020-03-20
CENTRIMAG MOTOR, USTHORATEC SWITZERLAND GMBH2020-03-19
CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUSTHORATEC SWITZERLAND GMBH2020-03-18
CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUSTHORATEC SWITZERLAND GMBH2020-03-18
BULK NON STER XCOAT DELPH PUMPTERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-03-17
BULK NON STER XCOAT DELPH PUMPTERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-03-17
HEART LUNG MACHINEMAQUET CARDIOPULMONARY GMBH2020-03-16
ROTAFLOWMAQUET CARDIOPULMONARY GMBH2020-03-16
HEART LUNG MACHINEMAQUET CARDIOPULMONARY GMBH2020-03-16
HEART LUNG MACHINEMAQUET CARDIOPULMONARY GMBH2020-03-16
HEART LUNG MACHINE2020-03-16
BULK NON STER XCOAT DELPH PUMPTERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-03-16
CENTRIMAG BLOOD PUMPTHORATEC SWITZERLAND GMBH2020-03-16
CENTRIMAG MOTOR, CANTHORATEC SWITZERLAND GMBH2020-03-16
ROTAFLOWMAQUET CARDIOPULMONARY GMBH2020-03-14
HEART LUNG MACHINEMAQUET CARDIOPULMONARY GMBH2020-03-14
HEART LUNG MACHINEMAQUET CARDIOPULMONARY GMBH2020-03-14
ROTAFLOWMAQUET CARDIOPULMONARY GMBH2020-03-14
TANDEMHEART PUMPCARDIACASSIST INC.2020-03-11
CENTRIMAG MOTOR, USTHORATEC SWITZERLAND GMBH2020-03-11
HEART LUNG MACHINEMAQUET CARDIOPULMONARY GMBH2020-03-10
HEART LUNG MACHINEMAQUET CARDIOPULMONARY GMBH2020-03-09
HEART LUNG MACHINEMAQUET CARDIOPULMONARY GMBH2020-03-09
HEART LUNG MACHINEMAQUET CARDIOPULMONARY GMBH2020-03-09
CENTRIMAG MOTOR, OUSTHORATEC SWITZERLAND GMBH2020-03-09
CENTRIMAG MOTOR, OUSTHORATEC SWITZERLAND GMBH2020-03-09
CENTRIMAG MOTOR, OUSTHORATEC SWITZERLAND GMBH2020-03-04
CENTRIMAG MOTOR, OUSTHORATEC SWITZERLAND GMBH2020-03-04
HEART LUNG MACHINEMAQUET CARDIOPULMONARY GMBH2020-03-03
HEART LUNG MACHINEMAQUET CARDIOPULMONARY GMBH2020-03-03
HEART LUNG MACHINEMAQUET CARDIOPULMONARY GMBH2020-03-02
BULK NON STER XCOAT DELPH PUMPTERUMO CARDIOVASCULAR SYSTEMS CORPORATION2020-02-28
CENTRIFUGAL PUMP CONSOLELIVANOVA DEUTSCHLAND GMBH2020-02-28
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICETHORATEC CORPORATION2020-02-27
CENTRIMAG MOTOR, OUSTHORATEC SWITZERLAND GMBH2020-02-24
HEART LUNG MACHINEMAQUET CARDIOPULMONARY GMBH2020-02-24
HEART LUNG MACHINEMAQUET CARDIOPULMONARY GMBH2020-02-22
HEART LUNG MACHINEMAQUET CARDIOPULMONARY GMBH2020-02-22
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