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

    DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED

    K Number: K914602 · Decision Nov 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    74
    Applicant Total
    5
    Review Days
    38

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    Basic Information

    Device Name
    DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED
    K Number
    K914602
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Heart Valve Div. Medtronic Cardiovascular Surg
    Date Received
    October 15, 1991
    Decision Date
    November 22, 1991
    Product Code
    KRH
    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
    KRH Ring, Annuloplasty

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    Other Clearances by The Heart Valve Div. Medtronic Cardiovascular Surg

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