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

    MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER

    K Number: K932228 · Decision Aug 10, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    23
    Applicant Total
    432
    Review Days
    95

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    Basic Information

    Device Name
    MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER
    K Number
    K932228
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Corp
    Date Received
    May 7, 1993
    Decision Date
    August 10, 1993
    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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