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510(k) Data Aggregation

    K Number
    K143613
    Device Name
    PaxWire Occlusion Balloon System
    Date Cleared
    2015-08-14

    (238 days)

    Product Code
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACCESSCLOSURE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PaxWire Occlusion Balloon System is indicated for temporary flow occlusion in the iliofemoral artery.
    Device Description
    The PaxWire™ Occlusion Balloon System (PaxWire System) is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during catheterization procedures. The PaxWire System consists of an occlusion catheter with a distal atraumatic stainless-steel J-tip, a compliant Chronoprene balloon, an 80 cm working length stainless steel shaft with a maximum 0.035" diameter proximal to the balloon, and an internal valve on the proximal end of the catheter. The effective length of the Pax Wire System is 99 cm with the inflation handle attached. The balloon can be inflated up to 12 mm for temporary flow occlusion in the iliofemoral artery. The balloon includes radiopaque markers located at each end of the balloon to aid positioning during fluoroscopy. The internal valve can be manually opened to control balloon inflation. The system also includes an inflation handle, a 10 cc Prep Syringe, and a 3 cc Inflation Syringe.
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