BEUDAMED
    FDA 510(k) FDA class 1 Unknown 🇺🇸 United States

    PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY

    K Number: K870420 · Decision Apr 14, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    23
    Applicant Total
    6
    Review Days
    70

    Basic Information

    Device Name
    PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY
    K Number
    K870420
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    NORTH COAST MEDI-TEK
    Date Received
    February 3, 1987
    Decision Date
    April 14, 1987
    Product Code
    GBZ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GBZ Catheter, Cholangiography

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