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

    LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052

    K Number: K090051 · Decision Oct 8, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    83
    Applicant Total
    11
    Review Days
    274

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    Basic Information

    Device Name
    LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052
    K Number
    K090051
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Levitronix, LLC
    Date Received
    January 7, 2009
    Decision Date
    October 8, 2009
    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
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    K093832 LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES
    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
    K051209 LEVITRONIX CENTRIMAG BACK-UP CONSOLE
    K020271 LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100
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