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

    POLYSTAN VERTICLUDE BLOOD PUMP

    K Number: K813035 · Decision Nov 27, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    20
    Applicant Total
    13
    Review Days
    30

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    Basic Information

    Device Name
    POLYSTAN VERTICLUDE BLOOD PUMP
    K Number
    K813035
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4370
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Advocacy International, Ltd.
    Date Received
    October 28, 1981
    Decision Date
    November 27, 1981
    Product Code
    DWB
    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
    DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type

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