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510(k) Data Aggregation

    K Number
    K252956

    Validate with FDA (Live)

    Device Name
    Helo Thrombectomy System
    Manufacturer
    Endovascular Engineering, Inc.
    Date Cleared
    2025-12-18

    (93 days)

    Product Code
    QEW
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    18 - 80
    Reference & Predicate Devices
    K222358
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Hēlo Thrombectomy System is indicated for:

    • The non-surgical removal of emboli and thrombi from pulmonary arteries and venous vasculature.
    • The system allows for injection, infusion, and/or aspiration of contrast media and other fluids into or from blood vessels.

    The Hēlo Thrombectomy System is intended for use in the peripheral veins and for the treatment of pulmonary embolism.

    The Hēlo Audible Flow Indicator is intended for use exclusively with the Hēlo Thrombectomy System and provides audible feedback of rapid flow through the device during a thrombectomy procedure.

    Device Description

    The Hēlo Thrombectomy System (Hēlo System) is a minimally invasive aspiration system designed for the removal of thromboembolic material from the pulmonary arteries. It can be initially introduced with a 16 Fr introducer sheath and expands to 8 mm at the distal portion once inside the vasculature. The Hēlo System allows for engagement with the targeted clot, aspiration of the targeted clot, and transportation of aspirated clot out of the body. The Hēlo System is supplied sterile using Ethylene Oxide gas and is intended for single-use only. The Hēlo System is comprised of the following components:

    • Aspiration Catheter: The Aspiration Catheter includes a funnel, an outer sleeve, and an integrated handle with controls. The handle also features a side port for the purposes of fluid injection, flushing of the inner lumen of the Aspiration Catheter, and for measurement of intravascular pressure using a standard pressure line setup, if needed. A second side port is used to purge air from the outer sleeve prior to use. The Aspiration Catheter is compatible with a 0.035" or 0.038" guidewire. It connects to a commercially available vacuum pump.

    • Agitator: The Agitator is intended to be inserted in the inner lumen of the Aspiration Catheter. It includes a drive unit that connects to the proximal end of the Aspiration Catheter. The Agitator is designed to mechanically disrupt emboli within the distal region of the Aspiration Catheter during aspiration. The Agitator may be disconnected, removed, and reintroduced through the Aspiration Catheter during use.

    • Rotating Hemostatic Valve (RHV): The RHV is an accessory that can be attached to the proximal end of the Aspiration Catheter when the Agitator is removed from the Aspiration Catheter. The RHV includes a Tuohy Borst valve to enable compatibility and sealing on ancillary devices, such as guidewires.

    • 9F Dilator: The 9F diameter, Dilator is an accessory that is compatible with 0.035" or 0.038" guidewires and can be used to facilitate navigation through the heart.

    • Audible Flow Indicator (AFI): The AFI is an optional accessory that connects between the suction port of the aspiration handle and the suction canister and provides audible feedback to the operator when actuation of the Suction/Agitator Control Button results in full flow through the device. A clot catcher made up of a coarse filter attaches to the suction canister and provides visualization of the clot.

    AI/ML Overview

    N/A

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