510(k) K103618 ยท MCW Catheter, Peripheral, Atherectomy
TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM
| Applicant | Ev3, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Jan 5, 2011 |
| Received | Dec 10, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103618
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.