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

    TRAC-WRIGHT SYSTEM, MODEL TW2

    K Number: K910594 · Decision Sep 23, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    74
    Review Days
    223

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    Basic Information

    Device Name
    TRAC-WRIGHT SYSTEM, MODEL TW2
    K Number
    K910594
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Dow Corning Wright
    Date Received
    February 12, 1991
    Decision Date
    September 23, 1991
    Product Code
    DXT
    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
    DXT Injector And Syringe, Angiographic

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