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

    PERIPHERAL AVE STENT SYSTEM

    K Number: K983008 · Decision Nov 25, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    2
    Review Days
    89

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    Basic Information

    Device Name
    PERIPHERAL AVE STENT SYSTEM
    K Number
    K983008
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Peripheral Ave
    Date Received
    August 28, 1998
    Decision Date
    November 25, 1998
    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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    Other Clearances by Peripheral Ave

    K Number Device Name
    K991533 MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION