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

    AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)

    K Number: K140561 · Decision Apr 23, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    49

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    Basic Information

    Device Name
    AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)
    K Number
    K140561
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5015
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xlumena, Inc.
    Date Received
    March 5, 2014
    Decision Date
    April 23, 2014
    Product Code
    PCU
    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
    PCU Pancreatic Stent, Covered, Metallic, Removable

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    Other Clearances by Xlumena, Inc.

    K Number Device Name
    DEN130007 AXIOS STENT AND DELIVERY SYSTEM