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

    ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI

    K Number: K912554 · Decision Sep 9, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    74
    Applicant Total
    505
    Review Days
    90

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    Basic Information

    Device Name
    ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI
    K Number
    K912554
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Baxter Healthcare Corp
    Date Received
    June 11, 1991
    Decision Date
    September 9, 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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