510(k) K042623 ยท DYB Introducer, Catheter
AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304
| Applicant | St. Jude Medical, Daig Division, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, Jan 27, 2005 |
| Received | Sep 27, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042623
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2006 | St. Jude Medical / Daig Division St. Jude AGILIS Steerable Introducer, Reorder number 408304 and 408308 (Australia). Sterile EO. St. Jude Medical Daig Division, Inc., Minnetonka, MN 55345-2126 USA. This St. Jude Medical (SJM) Agil Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.