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

    MEDISEAL SUCTION CANISTER

    K Number: K895427 · Decision Jan 19, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    14
    Applicant Total
    91
    Review Days
    136

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    Basic Information

    Device Name
    MEDISEAL SUCTION CANISTER
    K Number
    K895427
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4430
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Deroyal Industries, Inc.
    Date Received
    September 5, 1989
    Decision Date
    January 19, 1990
    Product Code
    DWD
    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
    DWD Suction Control, Intracardiac, Cardiopulmonary Bypass

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