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

    PROTEGE GPS SELF-EXPANDING NITINOL STENT

    K Number: K050725 · Decision Apr 20, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    5
    Review Days
    30

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    Basic Information

    Device Name
    PROTEGE GPS SELF-EXPANDING NITINOL STENT
    K Number
    K050725
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ev3 Corporation
    Date Received
    March 21, 2005
    Decision Date
    April 20, 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
    K051379 PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT
    K021096 X-SIZER CATHETER SYSTEM
    K031864 NITREX NITINOL GUIDEWIRE
    K024021 NITREX NITINOL GUIDEWIRE