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510(k) Data Aggregation

    K Number
    K082093
    Device Name
    BULLSEYE BILIARY STENT SYSTEM
    Manufacturer
    Date Cleared
    2009-07-29

    (370 days)

    Product Code
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    SQUAREONE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BullsEye Biliary Stent System is indicated for use in the palliation of malignant neoplasms in the biliary tree.
    Device Description
    The BullsEye Biliary Stent System is a 316L stainless steel, balloon-expandable stent design with a 6.2mm diameter and 15mm length (unexpanded). The stent is comprised of a distal cylindrical segment, which provides permanent structural support and subsequently restores and maintains bile flow by scaffolding the duct wall, and a 3.7mm proximal conformable flare segment, which helps to prevent post deployment stent migration and dislocation. The stent is pre-mounted on a dual-balloon, monorail, delivery device with 80cm working length and a crossing profile compatible with guide catheters/introducer sheaths with a minimum inner diameter of 0.081". The system is also compatible with standard 0.014″ guidewires. Two radiopaque marker bands aid in positioning of the stent during the delivery procedure.
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