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510(k) Data Aggregation

    K Number
    K131950
    Device Name
    ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
    Manufacturer
    SUMMIT INTERNATIONAL MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2015-01-16

    (568 days)

    Product Code
    FIE
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUMMIT INTERNATIONAL MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Angel Tip Safety Intravascular Needle Set is indicated to access the peripheral vascular system for hemodialysis. Additionally, after withdrawal of the needle from the patient's vein, the needle can be manually retracted within a safety enclosure to minimize the risk of an accidental needle stick.
    Device Description
    The safety needle portion of the Angel Tip Safety Intravascular Needle Set will be available in diameters ranging from 14 to 18 Ga and lengths of 1.0 to 1.5 inches. The Angel Tip Safety Intravascular Needle Sets are sterile, single use devices designed to access the peripheral vascular system for hemodialysis. Additionally, after withdrawal of the needle from the patient's vein, the needle can be manually retracted within a safety enclosure to minimize the risk of an accidental needle stick. The Angel Tip Safety Intravascular Needle Set consists of a needle attached to a winged hub, microbore or macrobore tubing, adapter and adapter cap and a safety enclosure that attaches to the winged hub. As the needle is removed from the patient's vessel, the user's finger actively slides the safety enclosure until it latches onto the needle using a one- or two-handed technique. The user will know the needle is engaged based on the tethers being fully extended and hearing an audible click. The safety enclosure is designed to allow the user's fingers to remain behind the needle point so that the risk of needle stick injury is minimized. The enclosure is clear so the user has a visual means of knowing the needle is captured.
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