FLOWRUNNER Aspiration System— 510(k) K254208

Substantially Equivalent

Expanse Medical, Inc.

FDA 510(k) clearance K254208 for FLOWRUNNER Aspiration System, Substantially Equivalent on 2026-03-20. Applicant: Expanse Medical, Inc..

Clearance details

Applicant: Expanse Medical, Inc.
Product code: Code QEZ
Advisory panel: Cardiovascular
Date received: 2025-12-29
Decision date: 2026-03-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QEZ

product code QEZ

Death: 24
Total: 24

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.