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510(k) Data Aggregation

    K Number
    K243627

    Validate with FDA (Live)

    Device Name
    Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)
    Manufacturer
    Arc Trauma, LLC
    Date Cleared
    2025-12-31

    (401 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K141685
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The L-ARC is indicated for use in the battlefield to control difficult bleeds inguinal area. The L-ARC is also indicated for use in the battlefield as a last resort for life threatening bleeds of the carotid artery.

    Device Description

    The Laryngoscope-Arterial Restriction Clamp is designed to be used by military medical personnel in the battlefield. The device is designed to control bleeding in the neck and inguinal areas where standard tourniquets cannot be used. The device can be used instead of manual pressure, allowing the medic to attend to other injuries or soldiers. The Laryngoscope-Arterial Restriction Clamp is use to control areas of difficult bleeding for up to 4 hours until the injured soldier can be transferred to evacuation personnel for further treatment or until the device can be converted to conventional dressings. The device can be used to directly visualize the oropharynx to assist with intubation in the soldier with a compromised airway.

    AI/ML Overview

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