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

    CRE DITATATION BALLON

    K Number: K112994 · Decision Feb 10, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    464
    Applicant Total
    193
    Review Days
    126

    Basic Information

    Device Name
    CRE DITATATION BALLON
    K Number
    K112994
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Corporation
    Date Received
    October 7, 2011
    Decision Date
    February 10, 2012
    Product Code
    FGE
    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
    FGE Stents, Drains And Dilators For The Biliary Ducts

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