510(k) K180694 ยท MCW Catheter, Peripheral, Atherectomy
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
| Applicant | Spectranetics, Inc., Colorado Springs CO, US |
| Decision | Substantially Equivalent, Apr 5, 2018 |
| Received | Mar 16, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180694
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.