BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    PERFADEX WITH THAM

    K Number: K081997 · Decision Oct 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    12
    Applicant Total
    38
    Review Days
    87

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    Basic Information

    Device Name
    PERFADEX WITH THAM
    K Number
    K081997
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5880
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vitrolife Sweden AB
    Date Received
    July 14, 2008
    Decision Date
    October 9, 2008
    Product Code
    MSB
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MSB System And Accessories, Isolated Heart, Transport And Preservation

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