K254208
- 510(k) number
- K254208
- Device name
- FLOWRUNNER Aspiration System
- Applicant
- Expanse Medical, Inc. CA · US
- Product code
- QEZ — Aspiration Thrombectomy Catheter
- Decision date
- 2026-03-20
- Date received
- 2025-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K254208.pdf
Official FDA record: K254208
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.