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

    DUROMEDICS CARDIAC VALVE SIZER SET

    K Number: K853313 · Decision Nov 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    86

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    Basic Information

    Device Name
    DUROMEDICS CARDIAC VALVE SIZER SET
    K Number
    K853313
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.3945
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Hemex Scientific, Inc.
    Date Received
    August 7, 1985
    Decision Date
    November 1, 1985
    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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