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510(k) Data Aggregation

    K Number
    K254040

    Validate with FDA (Live)

    Date Cleared
    2026-03-12

    (86 days)

    Product Code
    Regulation Number
    874.4680
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LungFlow Basket Catheter is intended to be used to endoscopically remove foreign bodies from the airway.

    Device Description

    The Free Flow Medical LungFlow Basket Catheter is a sterile, single use disposable foreign body retrieval device. The basket is designed to fully expand to make 360-degree contact with the airway wall to enable removal of foreign bodies which include inhaled objects or material, incidental medical debris, mucus, necrotic or potentially infective tissue or excised tissue from the airway, as the device is retracted proximally.

    The LungFlow Basket Catheter consists of a flexible coiled stainless steel wire trunk with a multi-wire 360-degree super-elastic nitinol basket at the distal end. The LungFlow Basket Catheter is designed to be delivered through the working channel (2.0mm and 2.8mm or larger) of an endoscope, such as a rigid or flexible bronchoscope.

    The LungFlow Basket Catheter is provided in configurations with a handle to manually assist the distal basket expansion or with a self-expanding distal basket.

    The LungFlow Basket Catheter may be delivered into distal lung airways using a compatible airway catheter if the catheter has been advanced through a therapeutic bronchoscope and into lung tissue with guidance provided by bronchoscope. Both manual expansion and self-expanding configurations are intended to be delivered distal to a foreign body before expansion. The LungFlow Basket Catheter will be provided in configurations that can expand up to 30mm in diameter. The basket is designed to fully expand to make 360-degree contact with the airway wall to enable reliable removal of foreign bodies from the airway.

    Each LungFlow Basket Catheter is individually packaged and sterilized using electron beam (e-beam) radiation.

    The LungFlow Basket Catheter is manufactured in the United States.

    AI/ML Overview

    N/A

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