510(k) K221077 ยท MCW Catheter, Peripheral, Atherectomy
Auryon Atherectomy System
| Applicant | Eximo Medical, Ltd., Rehovot, IL |
| Decision | Substantially Equivalent, Jun 9, 2022 |
| Received | Apr 12, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221077
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.