Cleared Special

FLOWRUNNER Aspiration System

K251488 · Expanse Medical, Inc. · Cardiovascular

Jul 2025

Decision

61d

Days

Class 2

Risk

About This 510(k) Submission

K251488 is an FDA 510(k) clearance for the FLOWRUNNER Aspiration System, a Aspiration Thrombectomy Catheter (Class II — Special Controls, product code QEZ), submitted by Expanse Medical, Inc. (Pleasanton, US). The FDA issued a Cleared decision on July 14, 2025, 61 days after receiving the submission on May 14, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number	K251488 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 14, 2025
Decision Date	July 14, 2025
Days to Decision	61 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QEZ — Aspiration Thrombectomy Catheter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5150
Definition	To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration.