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

    DUO FLOW CATHETER-MC 54

    K Number: K842416 · Decision Jul 26, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    9
    Applicant Total
    63
    Review Days
    36

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    Basic Information

    Device Name
    DUO FLOW CATHETER-MC 54
    K Number
    K842416
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Medical Components, Inc.
    Date Received
    June 20, 1984
    Decision Date
    July 26, 1984
    Product Code
    KNZ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNZ Accessories, A-V Shunt

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