510(k) K181642 ยท MCW Catheter, Peripheral, Atherectomy
B-Laser Atherectomy System
| Applicant | Eximo Medical, Ltd., Rehovot, IL |
| Decision | Substantially Equivalent, Oct 5, 2018 |
| Received | Jun 21, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181642
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.