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

    ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK

    K Number: K915301 · Decision Dec 11, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    144
    Same Product Code
    136
    Applicant Total
    32
    Review Days
    386

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    Basic Information

    Device Name
    ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK
    K Number
    K915301
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4290
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advance Medical Designs, Inc.
    Date Received
    November 21, 1991
    Decision Date
    December 11, 1992
    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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