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

    DETLOGIX ANNULOPLASTY RING, MODEL: 5100

    K Number: K083191 · Decision Apr 10, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    68
    Applicant Total
    77
    Review Days
    163

    Basic Information

    Device Name
    DETLOGIX ANNULOPLASTY RING, MODEL: 5100
    K Number
    K083191
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    EDWARDS LIFESCIENCES, LLC.
    Date Received
    October 29, 2008
    Decision Date
    April 10, 2009
    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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