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510(k) Data Aggregation

    K Number
    K250960
    Device Name
    DUO Microcatheter
    Manufacturer
    REV Neuro LLC
    Date Cleared
    2025-09-08

    (161 days)

    Product Code
    QJP,DQO,DQY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K211594
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DUO Microcatheter is intended for the selective placement of devices and/or fluids, such as contrast media, into the peripheral, coronary, and neuro vasculature during diagnostic and/or therapeutic procedures.

    Device Description

    The DUO Microcatheter is a disposable, single use, sterile device. The DUO Microcatheter is a single-lumen, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 80 cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. Device dimensions and configuration are shown on the product label. A steam shaping mandrel and a peel away introducer are provided with each microcatheter.

    AI/ML Overview

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