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

    FLEXIBLE INTRACARDIAC SUCTION DEVICE

    K Number: K905008 · Decision Jan 23, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    8
    Applicant Total
    75
    Review Days
    78

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    Basic Information

    Device Name
    FLEXIBLE INTRACARDIAC SUCTION DEVICE
    K Number
    K905008
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4420
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Gish Biomedical, Inc.
    Date Received
    November 6, 1990
    Decision Date
    January 23, 1991
    Product Code
    DTS
    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
    DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass

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