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

    COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT

    K Number: K896197 · Decision Jul 11, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    150
    Applicant Total
    1
    Review Days
    257

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    Basic Information

    Device Name
    COLAB COCATH(TM) IMPLANTED CATHETER AND DEPOT
    K Number
    K896197
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Colab Intl., Inc.
    Date Received
    October 27, 1989
    Decision Date
    July 11, 1990
    Product Code
    KXK
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KXK Source, Brachytherapy, Radionuclide

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