BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS

    K Number: K864155 · Decision Nov 20, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    11
    Applicant Total
    89
    Review Days
    28

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    Basic Information

    Device Name
    MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS
    K Number
    K864155
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.3935
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    American Edwards Laboratories
    Date Received
    October 23, 1986
    Decision Date
    November 20, 1986
    Product Code
    DTJ
    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
    DTJ Holder, Heart-Valve, Prosthesis

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