510(k) K061363 ยท DYB Introducer, Catheter
AGILIS NXT STEERABLE INTRODUCER
| Applicant | St Jude Medical, Minnetonka MN, US |
| Decision | Substantially Equivalent, Jul 12, 2006 |
| Received | May 16, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061363
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2024 | St. Jude Medical St. Jude Medical Agilis NxT Steerable Introducer, REF 408309 Open, Classified |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.