510(k) K012922 ยท DYB Introducer, Catheter
ULTRAFLEX EV HEMOSTASIS INTRODUCER
| Applicant | St Jude Medical, Minnetonka MN, US |
| Decision | Substantially Equivalent, Sep 25, 2001 |
| Received | Aug 31, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012922
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.