510(k) K984260 ยท DYB Introducer, Catheter
PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR)
| Applicant | Terumo Medical Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Jan 26, 1999 |
| Received | Nov 25, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K984260
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.