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510(k) Data Aggregation

    K Number
    K140768
    Device Name
    TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT
    Date Cleared
    2014-11-25

    (243 days)

    Product Code
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEPU MEDICAL TECHNOLOGY (BEJING) CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Brilliant™ Introducer Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such introduction.
    Device Description
    The BrilliantTM Introducer Kit classifies into four types (Type I, II, III, and IV). Type I and II consists of a sheath introducer, a dilator, a guide wire with a guide wire collimator, a puncture needle; Type III consists of a sheath introducer, a dilator, a guide wire with a guide wire collimator; and Type IV consists of a sheath introducer, a dilator, a guide wire with a guide wire collimator, an intravascular catheter with introducer needle, a scalpel and a syringe. The puncture needle or an intravascular catheter incorporates a lumen, which provides a conduit for the insertion of the guide wire into the vascular system. The various types of guide wires, model dependent, are utilized as a guiding mechanism for the insertion of the introduction sheath into the vascular system. The guide wire contains a wire collimator, which assists in funneling the wire through the lumen of the puncture needle or the intravascular catheter and contains marking that are visible under fluoroscopy, which can determine the length of the guide wire within the vascular system. The sheath introducer provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vasculature. The main components of the sheath introducer assembly are a hydrophilic coated sheath introducer, hemostasis valve housing, and a side port with tubing connected to a 3-way stopcock/valve. The hydrophilic coated dilator is used to provide support and stability to the sheath introducer during deployment into the vascular system. The proximal end of the dilator includes a luer port and has a tapered, atraumatic distal tip. Both the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.
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