FLOWRUNNER Aspiration System

FDA 510(k) K254208 · Expanse Medical, Inc.

Substantially Equivalent

510(k) numberK254208

Submission

Device name
FLOWRUNNER Aspiration System
Applicant
Expanse Medical, Inc.
Pleasanton, CA, US
Received
December 29, 2025
Decision date
March 20, 2026
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QEZ – Aspiration Thrombectomy Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5150
Specialty
Cardiovascular

To remove thrombus from the peripheral and/or coronary vasculature through aspiration.

Other 510(k)s with product code QEZ

510(k)DeviceApplicantDecision
K254035Mayumi™ Thrombectomy SystemQEZ · Traditional MicroVention, Inc., d/b/a Terumo Neuro09/03/2026SE
K261105Powered Aventus Thrombectomy System™QEZ · Traditional Inquis Medical07/27/2026SE
K262030Aventus Thrombectomy SystemQEZ · Special Inquis Medical07/15/2026SE
K253589Liberant™ RX Aspiration CatheterQEZ · Traditional Medtronic Interventional Vascular, Inc.04/23/2026SE
K253925Aventus Thrombectomy SystemQEZ · Traditional Inquis Medical01/15/2026SE
K252509AlphaVac Multipurpose Mechanical Aspiration System F1885QEZ · Traditional AngioDynamics, Inc.11/24/2025SE
K251312Vesalio Peripheral SystemQEZ · Traditional Vesalio, Inc.10/24/2025SE
K251488FLOWRUNNER Aspiration SystemQEZ · Special Expanse Medical, Inc.07/14/2025SE
K243549JETi Hydrodynamic Thrombectomy SystemQEZ · Traditional Abbott Medical04/04/2025SE
K250013VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S…QEZ · Special Control Medical Technology, Inc. / Dba Ventiv…03/24/2025SE

More from Control Medical Technology, Inc. / Dba Ventiv Scientific

510(k)DeviceDecision
K251488FLOWRUNNER Aspiration SystemQEZ · Special 07/14/2025SE
K234073ICE Aspiration SystemQEW · Traditional 04/19/2024SE

Questions and answers

When was FLOWRUNNER Aspiration System cleared by the FDA?

FLOWRUNNER Aspiration System (K254208) received a 510(k) decision of Substantially Equivalent on March 20, 2026, 81 days after the submission was received.

What is the product code of K254208?

The FDA product code is QEZ – Aspiration Thrombectomy Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.5150.