510(k) K090867 ยท DYB Introducer, Catheter
AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002
| Applicant | Ep Dynamics, Inc., Mission Viejo CA, US |
| Decision | Substantially Equivalent, Jul 30, 2009 |
| Received | Mar 31, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090867
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.