510(k) clearance

FLOWRUNNER Aspiration System

FDA 510(k) source

510(k) number

K262864

Applicant

Expanse Medical, Inc.

Decision date

Oct 26, 2026

Date received

Aug 14, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

QEZ

Device type

Aspiration Thrombectomy Catheter

Device class

Class II

Regulation

21 CFR 870.5150

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

Pleasanton, CA, US