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    K Number
    K040139
    Device Name
    ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER
    Manufacturer
    ENDOBIONICS, INC.
    Date Cleared
    2004-02-18

    (27 days)

    Product Code
    KRA
    Regulation Number
    870.1210
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDOBIONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In selective areas of 2.5 mm diameter peripheral and coronary vessels, the uSyringe Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents that are indicated for delivery into the vessel wall or perivascular area. The uSyringe Infusion Catheter is also intended for the infusion of diagnostic and therapeutic agents intraluminally.
    Device Description
    The EndoBionics uSyringe is a wire-gulded endovascular catheter that consists of a perpendicular microneedle delivery port, which is sheathed by and contained within a semi-rigid polymer balloon actuator. The device is advanced over a 0.014" guidewire, using a single operator method, into the treatment vessel and hydraulically actuated to move the needle delivery port into the vessel in order to deliver substances to 2.5 min vascular structures.
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