510(k) K080415 ยท DYB Introducer, Catheter
DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
| Applicant | Terumo Medical Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Mar 7, 2008 |
| Received | Feb 14, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080415
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.