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

    HYDROFIX VASO SHIELD

    K Number: K111137 · Decision May 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    28

    Basic Information

    Device Name
    HYDROFIX VASO SHIELD
    K Number
    K111137
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.3470
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    MIMEDX GROUP INC
    Date Received
    April 22, 2011
    Decision Date
    May 20, 2011
    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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