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

    HERO GRAFT

    K Number: K124039 · Decision Mar 7, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    187
    Applicant Total
    1
    Review Days
    69

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    Basic Information

    Device Name
    HERO GRAFT
    K Number
    K124039
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemoshpere, Inc., A Cryolife Company
    Date Received
    December 28, 2012
    Decision Date
    March 7, 2013
    Product Code
    DSY
    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
    DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

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