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    K Number
    K254208

    Validate with FDA (Live)

    Device Name
    FLOWRUNNER Aspiration System
    Manufacturer
    Expanse Medical, Inc.
    Date Cleared
    2026-03-20

    (81 days)

    Product Code
    QEZ
    Regulation Number
    870.5150
    Type
    Special
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    K234073,K251488
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K234073

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The FLOWRUNNER Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

    Device Description

    The FLOWRUNNER Aspiration System is a peripheral thrombectomy system consisting of several components:

    • FLOWRUNNER Aspiration Catheter
    • FLOWRUNNER Aspiration Sheath
    • Vacuum Fitting
    • High Flow Stopcock Connector
    • Y-Connector with Hemostatic Valve
    • Hand Actuator Clip

    The FLOWRUNNER Aspiration System family is designed for the minimally invasive removal of thrombus from the peripheral vasculature using aspiration. The extension of the device family includes smaller-diameter sizes of the FLOWRUNNER Aspiration System. The system is a single-use catheter-based device with the capability to infuse fluids.

    FLOWRUNNER SP Aspiration System is over the wire system.

    FLOWRUNNER Aspiration System consists of one aspiration catheter, one aspiration sheath, one vacuum fitting, one high flow stopcock connector, one Y-connector with hemostatic valve, and a hand actuator clip.

    The FLOWRUNNER Aspiration System is introduced to the site of the primary occlusion. The Aspiration Catheter is advanced through the Aspiration Sheath and targets aspiration directly to the thrombus. The Aspiration Catheter is then retracted back into the Aspiration Sheath. This process of extension and retraction of the Aspiration Catheter is then repeated to fully aspirate the clot. Suction is applied directly to the Aspiration Catheter from an external vacuum source to aspirate thrombus from an occluded vessel (maximum pressure -27.6 in Hg and minimum pressure of -8.0 in Hg).

    Sterile saline flows through the Aspiration Sheath and into the Aspiration Catheter when connected proximally. The Aspiration Catheter and Sheath are visible under fluoroscopy. The hand actuator is an optional, proximal clip attached to the Aspiration Catheter to assist the user.

    The FLOWRUNNER Aspiration System comes in 7F, SP 7F, 12F, and 14F compatible diameters and 60cm, 80cm, 100cm, 120 and 130cm lengths.

    AI/ML Overview

    N/A

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