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510(k) Data Aggregation

    K Number
    K252508

    Validate with FDA (Live)

    Device Name
    Intri26 Introducer Sheath
    Manufacturer
    Inari Medical, Inc.
    Date Cleared
    2025-12-17

    (131 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K213402,K121234,K233646
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Intri26 Introducer Sheath is indicated:

    • To provide a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.
    • For the injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
    Device Description

    The Intri26 Introducer Sheath is an introducer sheath consisting of a short, single-lumen catheter with a hydrophilic coating, proximal hemostasis valve, and stopcock with flush port. A radiopaque marker is positioned near the distal tip of the sheath to aid fluoroscopic visualization. The Intri26 dilator is compatible with a 0.035" guidewire and has a tapered leading edge, which aids insertion and positioning of the sheath.

    AI/ML Overview

    N/A

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