510(k) K250385 ยท MCW Catheter, Peripheral, Atherectomy
Turbo-Elite Laser Atherectomy Catheter
| Applicant | Spectranetics, Colorado Springs CO, US |
| Decision | Substantially Equivalent, Mar 13, 2025 |
| Received | Feb 11, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K250385
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.