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

    GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING

    K Number: K081838 · Decision Jan 26, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    90
    Applicant Total
    75
    Review Days
    210

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    Basic Information

    Device Name
    GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING
    K Number
    K081838
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gish Biomedical, Inc.
    Date Received
    June 30, 2008
    Decision Date
    January 26, 2009
    Product Code
    DTR
    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
    DTR Heat-Exchanger, Cardiopulmonary Bypass

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    Other Clearances by Gish Biomedical, Inc.

    K Number Device Name
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    K082403 MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT
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