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

    PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE

    K Number: K874405 · Decision Dec 30, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    11
    Applicant Total
    28
    Review Days
    63

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    Basic Information

    Device Name
    PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE
    K Number
    K874405
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4270
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Pall Biomedical Products Co.
    Date Received
    October 28, 1987
    Decision Date
    December 30, 1987
    Product Code
    JOD
    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
    JOD Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass

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