510(k) K082847 ยท DYB Introducer, Catheter
PINNACLE ROII INTRODUCER SHEATH
| Applicant | Terumo Medical Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Oct 29, 2008 |
| Received | Sep 29, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082847
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.