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

    IBC CARDIAC SUCTION WARD

    K Number: K963756 · Decision Nov 14, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    8
    Applicant Total
    11
    Review Days
    423

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    Basic Information

    Device Name
    IBC CARDIAC SUCTION WARD
    K Number
    K963756
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4420
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    International Biophysics Corp.
    Date Received
    September 17, 1996
    Decision Date
    November 14, 1997
    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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