BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    POSTERIOR ANNULOPLASTY BAND (MODEL 607)

    K Number: K960356 · Decision Aug 27, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    74
    Applicant Total
    5
    Review Days
    215

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    Basic Information

    Device Name
    POSTERIOR ANNULOPLASTY BAND (MODEL 607)
    K Number
    K960356
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    The Heart Valve Div. Medtronic Cardiovascular Surg
    Date Received
    January 25, 1996
    Decision Date
    August 27, 1996
    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

    K Number Device Name
    K980534 DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H
    K944956 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491
    K922269 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493
    K914602 DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED