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

    JOSTRA MECC SYSTEM

    K Number: K023132 · Decision Dec 17, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    83
    Applicant Total
    13
    Review Days
    88

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    Basic Information

    Device Name
    JOSTRA MECC SYSTEM
    K Number
    K023132
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jostra AG
    Date Received
    September 20, 2002
    Decision Date
    December 17, 2002
    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 Jostra AG

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    K020784 JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS
    K022022 JOSTRA VENT CATHETERS, MODELS LV & HKV
    K020515 JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA
    K014303 JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE
    K013944 JOSTRA DUAL STAGE VENOUS RETURN CANNULAE
    K013939 JOSTRA FLOWPROBE FP-32E
    K012774 JOSTRA ARTERIAL PERFUSION CANNULAE
    K012617 JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A...
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