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FLOWRUNNER 14F Aspiration System, 120cm

Expanse Medical, Inc. · Model FLWRNR12014 · UDI-DI 00860011713142

QEZ KRA Prescription

510(k) clearances

Adverse events (25 deaths)

Recalls

Facilities

Description

The Expanse FLOWRUNNER Aspiration System is a peripheral thrombectomy system consisting of several components: - FLOWRUNNER Aspiration Catheter - FLOWRUNNER Aspiration Sheath - Vacuum Fitting - High Flow Stopcock - Y-Connector with Hemostatic Valve - Hand Actuator Clip. The FLOWRUNNER Aspiration System is designed for the minimally invasive removal of thrombus from the peripheral vasculature using aspiration. It is a single use, over-the-wire, catheter-based system. The 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 one hand actuator clip.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.