510(k) K111092 ยท DYB Introducer, Catheter
ENGAGE/ENGAGE TR INTRODUCERS
| Applicant | St Jude Medical, Minnetonka MN, US |
| Decision | Substantially Equivalent, Jun 9, 2011 |
| Received | Apr 19, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111092
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.