510(k) K001346 ยท DYB Introducer, Catheter
ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX
| Applicant | St. Jude Medical, Inc., Minnetonka MN, US |
| Decision | Substantially Equivalent, May 24, 2000 |
| Received | Apr 28, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001346
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.