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510(k) Data Aggregation

    K Number
    K961982
    Device Name
    TRI-FLOW THREE WAY STOPCOCK
    Manufacturer
    Date Cleared
    1997-02-21

    (277 days)

    Product Code
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    NORTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Similar in intended use to the selected legally marketed devices, the Tri-Flow™ 3-Way Stopcock is designed to be used in any medical procedure where controlled flow of fluid is required. It is specifically designed to be used in procedures where three different fluids are administered into one line.
    Device Description
    The Tri-Flow™ 3-Way Stopcock is a disposable stopcock designed for one time use. The device consists of three injection molded components: a body, a stem/handle, and a swivel nut. A small amount of medical grade fluid is used as a lubricant to reduce friction at the stem/body interface. The body contains for fluid flow. Three channels end in female luer ports and the other channel terminates as a male luer port. The swivel nut is press fit onto the male luer port. The stopcock body has a cylindrical bore intersecting all four channels into which the stem/handle is press fit mounted. The stem/handle contains two independent passageways. A fluid pathway can be created between the male luer port and only one, of the three female ports. This is achieved by rotating the stem/handle to one of three distinct positions. The word "ON" located on the stem/handle signifies which ports are connected. In either extreme handle straddles the two ports which are connected. In the center position, the handle aligns with and indicates a straight flow pathway.
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