510(k) K111606 ยท DYB Introducer, Catheter
PINNACLE PRECISION ACCESS SYSTEM
| Applicant | Terumo Medical Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Oct 3, 2011 |
| Received | Jun 9, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111606
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2016 | Terumo Medical Corporation PINNACLE Introducer Sheath
PINNACLE PRECISION ACCESS SYSTEM Sheath
PINNACLE TIF TIP" Introducer Sheath
PINNACLE R/O II Radiopaque Marker Introducer Sheath Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.