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

    EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET

    K Number: K881279 · Decision May 18, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    6
    Applicant Total
    505
    Review Days
    57

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    Basic Information

    Device Name
    EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET
    K Number
    K881279
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.3945
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Baxter Healthcare Corp
    Date Received
    March 22, 1988
    Decision Date
    May 18, 1988
    Product Code
    DTI
    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
    DTI Sizer, Heart-Valve, Prosthesis

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