510(k) K111485 ยท DQX Wire, Guide, Catheter
FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, Jun 30, 2011 |
| Received | May 31, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111485
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.