510(k) K111943 ยท DYB Introducer, Catheter
AGILLS PF DELIVERY SYSTEM
| Applicant | St. Jude Medical, Cardiac Rhythm Management Divisi, Sylmar CA, US |
| Decision | Substantially Equivalent, Sep 29, 2011 |
| Received | Jul 8, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111943
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.