510(k) K081645 ยท DYB Introducer, Catheter
AGILIS NXT STEERABLE INTRODUCER, MODEL G408324
| Applicant | St Jude Medical, Minnetonka MN, US |
| Decision | Substantially Equivalent, Dec 9, 2008 |
| Received | Jun 12, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081645
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.