510(k) K254022 · LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
FLASH Flex Aorto-Ostial Angioplasty System
| Applicant | Verge Medical, Inc., Campbell CA, US |
| Decision | Substantially Equivalent, Apr 2, 2026 |
| Received | Dec 16, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254022
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.