510(k) K092014 ยท DYB Introducer, Catheter
SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
| Applicant | Onset Medical Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, Oct 8, 2009 |
| Received | Jul 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092014
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.