510(k) K111603 ยท DYB Introducer, Catheter
LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM
| Applicant | Ep Dynamics, Inc., Mission Viejo CA, US |
| Decision | Substantially Equivalent, Aug 23, 2012 |
| Received | Jun 8, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111603
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.