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510(k) Data Aggregation

    K Number
    K201076
    Device Name
    Anchor Dual Lumen Guidewire Catheter
    Date Cleared
    2020-08-06

    (106 days)

    Product Code
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aqure Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Anchor Dual Lumen Guidewire Catheter is intended for use in the peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional devices.
    Device Description
    The Anchor Dual Lumen Guidewire Catheter, model AQ8001, is a single use, sterile (EO), 8F, 110 cm (working length of 100 cm) biocompatible, flexible, radiopaque, dual lumen catheter with a 6F, C shaped tip. The shaft utilizes a braided wire design with multiple Pebax durometer extrusions reflowed over PTFE liner. The distal tip includes radiopaque marker bands for visibility under fluoroscopy. The larger lumen accommodates an 0.035" guidewire and other interventional devices; the smaller lumen allows a 0.014" guidewire to exit the catheter at the curve to provide stabilization of the catheter. The hub, with Luer fittings, is compatible with standard syringes and is leak proof. The hub is marked to identify the lumens.
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