510(k) K083402 ยท DYB Introducer, Catheter
AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323
| Applicant | St Jude Medical, Minnetonka MN, US |
| Decision | Substantially Equivalent, Dec 15, 2008 |
| Received | Nov 18, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083402
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.