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

    PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT

    K Number: K051379 · Decision Jun 17, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    5
    Review Days
    21

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    Basic Information

    Device Name
    PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT
    K Number
    K051379
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Ev3 Corporation
    Date Received
    May 27, 2005
    Decision Date
    June 17, 2005
    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 Ev3 Corporation

    K Number Device Name
    K050725 PROTEGE GPS SELF-EXPANDING NITINOL STENT
    K021096 X-SIZER CATHETER SYSTEM
    K031864 NITREX NITINOL GUIDEWIRE
    K024021 NITREX NITINOL GUIDEWIRE