510(k) K062446 ยท DYB Introducer, Catheter
MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH
| Applicant | Terumo Medical Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Oct 23, 2006 |
| Received | Aug 22, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062446
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.