K254022
- 510(k) number
- K254022
- Device name
- FLASH Flex Aorto-Ostial Angioplasty System
- Applicant
- Verge Medical, Inc. CA · US
- Product code
- LOX — Catheters, Transluminal Coronary Angioplasty, Percut
- Decision date
- 2026-04-02
- Date received
- 2025-12-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K254022.pdf
Official FDA record: K254022
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.