510(k) K141801 ยท MCW Catheter, Peripheral, Atherectomy
HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
| Applicant | Covidien, LLC, Plymouth MN, US |
| Decision | Substantially Equivalent, Oct 16, 2014 |
| Received | Jul 3, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141801
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.