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

    DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H

    K Number: K893678 · Decision Nov 27, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    74
    Applicant Total
    15
    Review Days
    195

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    Basic Information

    Device Name
    DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H
    K Number
    K893678
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medtronic Blood Systems, Inc.
    Date Received
    May 16, 1989
    Decision Date
    November 27, 1989
    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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