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

    CYTOSTATIC FILTRATION SET

    K Number: K863218 · Decision Feb 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    15
    Applicant Total
    24
    Review Days
    176

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    Basic Information

    Device Name
    CYTOSTATIC FILTRATION SET
    K Number
    K863218
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Meadox Surgimed, Inc.
    Date Received
    August 20, 1986
    Decision Date
    February 12, 1987
    Product Code
    LFK
    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
    LFK Catheter, Femoral

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