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

    XYLOS VESSEL GUARD

    K Number: K100984 · Decision Jul 7, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    9
    Applicant Total
    9
    Review Days
    90

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    Basic Information

    Device Name
    XYLOS VESSEL GUARD
    K Number
    K100984
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3470
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Xylos Corporation
    Date Received
    April 8, 2010
    Decision Date
    July 7, 2010
    Product Code
    OMR
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OMR Vessel Guard Or Cover

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