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

    CHOLANGIOLAPCATH(TM)

    K Number: K921091 · Decision May 6, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    23
    Applicant Total
    632
    Review Days
    61

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    Basic Information

    Device Name
    CHOLANGIOLAPCATH(TM)
    K Number
    K921091
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    March 6, 1992
    Decision Date
    May 6, 1992
    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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