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510(k) Data Aggregation

    K Number
    K173266
    Device Name
    Octane aspiration system
    Manufacturer
    Vascular Solutions Inc.
    Date Cleared
    2017-12-01

    (51 days)

    Product Code
    QEZ, DXE
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vascular Solutions Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Octane aspiration system is intended for the removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial and deep venous system, and to infuse/deliver diagnostic or therapeutic agents.
    Device Description
    The Octane aspiration system consists of two components: the Octane catheter and the Octane hand pump. The Octane aspiration catheter has a working length of 115cm, is compatible with introducer sheaths ≥ 8F, guidewires ≤ 0.018" in diameter, and it is intended for use in vessels ≥ 3 mm in diameter. The catheter has a rapid exchange design and includes sliding, co-axial inner and outer lumens. The catheter inner lumen tip has three side wall slot ports and the catheter's outer lumen has a beveled radiopaque tip. To alleviate plugging of the catheter tip caused by thrombus, the actuator on the proximal end of the catheter slides the catheter's outer lumen back and forth over the inner lumen distal tip. The actuator on the proximal end of the catheter is also used to control the directionality of the torque-able catheter. Directionality is further achieved through the gradual curve in the shaft materials at the distal end. The Octane hand pump provides suction to the inner lumen of the Octane aspiration catheter and is manually operated using a spring-loaded handle. It consists of a pump handle fitted with a 30ml piston syringe, tubing, a series of one-way valves, and a 500ml collection bag. The hand pump tubing has a standard luer fitting for connection to the Octane aspiration catheter hub. The Octane aspiration system has been sterilized with ethylene oxide.
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