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

    GISH ARTERIAL FILTER WITH GBS COATING

    K Number: K023833 · Decision Mar 31, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    95
    Applicant Total
    75
    Review Days
    133

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    Basic Information

    Device Name
    GISH ARTERIAL FILTER WITH GBS COATING
    K Number
    K023833
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4260
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gish Biomedical, Inc.
    Date Received
    November 18, 2002
    Decision Date
    March 31, 2003
    Product Code
    DTM
    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
    DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

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