510(k) K170191 ยท MCW Catheter, Peripheral, Atherectomy
SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System
| Applicant | Medtronic Vascular, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Jun 16, 2017 |
| Received | Jan 23, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K170191
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.