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

    ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM

    K Number: K072708 · Decision Aug 18, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    464
    Applicant Total
    6
    Review Days
    328

    Basic Information

    Device Name
    ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM
    K Number
    K072708
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Date Received
    September 25, 2007
    Decision Date
    August 18, 2008
    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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