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

    FOGARTY VESSEL CALIBRATOR

    K Number: K902143 · Decision Oct 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    19
    Applicant Total
    505
    Review Days
    154

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    Basic Information

    Device Name
    FOGARTY VESSEL CALIBRATOR
    K Number
    K902143
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4475
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Baxter Healthcare Corp
    Date Received
    May 15, 1990
    Decision Date
    October 16, 1990
    Product Code
    DWP
    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
    DWP Dilator, Vessel, Surgical

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