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

    CORONARY VEIN GRAFT TAG MARKER

    K Number: K971966 · Decision Jan 26, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    243

    Basic Information

    Device Name
    CORONARY VEIN GRAFT TAG MARKER
    K Number
    K971966
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4650
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    MED-EDGE, INC.
    Date Received
    May 28, 1997
    Decision Date
    January 26, 1998
    Product Code
    KPK
    Advisory Committee
    General, Plastic Surgery
    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
    KPK Marker, Ostia, Aorto-Saphenous Vein

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