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

    AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E

    K Number: K090914 · Decision Jul 16, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    52
    Applicant Total
    6
    Review Days
    106

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    Basic Information

    Device Name
    AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E
    K Number
    K090914
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5900
    Medical Specialty
    Radiology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Xoft, Inc.
    Date Received
    April 1, 2009
    Decision Date
    July 16, 2009
    Product Code
    JAD
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JAD System, Therapeutic, X-Ray

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