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

    DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)

    K Number: K954713 · Decision Jul 24, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    15
    Review Days
    288

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    Basic Information

    Device Name
    DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)
    K Number
    K954713
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ideas For Medicine, Inc.
    Date Received
    October 10, 1995
    Decision Date
    July 24, 1996
    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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