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510(k) Data Aggregation

    K Number
    K101838
    Device Name
    VTS1000
    Date Cleared
    2011-02-18

    (232 days)

    Product Code
    Regulation Number
    880.6970
    Why did this record match?
    Applicant Name (Manufacturer) :

    VUETEK SCIENTIFIC LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VTS1000 is a non-invasive electronic device to aid in the visualization of superficial vasculature. It is indicated for use during procedures requiring vascular or peripheral vessel access.
    Device Description
    The VueTek Scientific™ VTS1000 is a near-infrared (NIR) emitter, video acquisition, and head mounted display (HMD) device that affords viewing of superficial, and its nead invanced and, by differentiating it with higher contrast from surrounding tissue. Visualization of vascular structures is provided by a portable headset display system which supplements normal line of sight viewing during vascular access procedures. The VTS1000 device does not replace the accepted conventional vascular identification and confirmation methods used by qualified professionals.
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