BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LEVITRONIX CENTRIMAG BACK-UP CONSOLE

    K Number: K051209 · Decision Sep 8, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    83
    Applicant Total
    11
    Review Days
    120

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    Basic Information

    Device Name
    LEVITRONIX CENTRIMAG BACK-UP CONSOLE
    K Number
    K051209
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Levitronix, LLC
    Date Received
    May 11, 2005
    Decision Date
    September 8, 2005
    Product Code
    KFM
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

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    Other Clearances by Levitronix, LLC

    K Number Device Name
    K110983 CENTRIMAG DRAINAGE CANNULA KIT
    K110980 CENTRIMAG RETURN CANNULA KIT
    K102129 LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR
    K093832 LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES
    K090051 LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052
    K090004 LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLES
    K083340 LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRIMARY CONSOLE
    K081221 LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE
    K053630 LEVITRONIX CENTRIMAG PRIMARY CONSOLE
    K020271 LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100
    Search all 11 clearances from Levitronix, LLC →