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FDA 510(k)

FLOWRUNNER Aspiration System

K-Number: K254208 · 2026-03-20

ApplicantExpanse Medical, Inc.
Decision Date2026-03-20
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLOWRUNNER Aspiration System is a medical device manufactured by Expanse Medical, Inc.. It received FDA 510(k) clearance on 2026-03-20 under approval number K254208. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOWRUNNER Aspiration System?

FLOWRUNNER Aspiration System is a medical device that received FDA 510(k) clearance on 2026-03-20. It is manufactured by Expanse Medical, Inc.. The 510(k) number is K254208.

When was FLOWRUNNER Aspiration System approved by the FDA?

FLOWRUNNER Aspiration System received FDA 510(k) clearance on 2026-03-20, under approval number K254208.

What company makes FLOWRUNNER Aspiration System?

FLOWRUNNER Aspiration System is manufactured by Expanse Medical, Inc..

What is the FDA product code for FLOWRUNNER Aspiration System?

The FDA product code for FLOWRUNNER Aspiration System is QEZ.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT07491952 Continuous Dual Aspiration Technique With Zoom System for Stroke RECRUITING NCT06747117 A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo™ Aspiration System (STRIDE II) RECRUITING NCT07101809 Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology RECRUITING NCT04798261 Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System RECRUITING NCT07350499 Aspiration Thrombectomy Using the Symphony or Prodigy System RECRUITING

Other Devices by Expanse Medical, Inc.

K234073ICE Aspiration System K251488FLOWRUNNER Aspiration System

Related Devices (Code: QEZ)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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