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510(k) Data Aggregation

    K Number
    K073444
    Device Name
    TRITON MEIDCAL TMED IV-SET
    Manufacturer
    TRITON MEDICAL, LLC
    Date Cleared
    2008-08-18

    (255 days)

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

    TRITON MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Triton Medical TMed IV-Set is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a ven. The device is for prescription use only.
    Device Description
    Depending on configuration, the device may include the following; protective cap(s), drip chamber, tubing, back check valve(s), anti-siphon valve, needle free Y-site, roller clamp, 0.22 micron filter or 1.2 micron filter, male Luer lock, spike, and medi-hook.
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