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

    MEDI-PLAST DISPOSABLE MANIFOLD

    K Number: K863402 · Decision Oct 22, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    144
    Same Product Code
    136
    Applicant Total
    12
    Review Days
    49

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    Basic Information

    Device Name
    MEDI-PLAST DISPOSABLE MANIFOLD
    K Number
    K863402
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4290
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medi-Plast Intl., Inc.
    Date Received
    September 3, 1986
    Decision Date
    October 22, 1986
    Product Code
    DTL
    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
    DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

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    K840022 HEART CATHETERIZATION TRAY SET
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