510(k) K121404 ยท DYB Introducer, Catheter
SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM
| Applicant | Onset Medical Corporation, Irvine CA, US |
| Decision | Substantially Equivalent, May 3, 2013 |
| Received | May 10, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121404
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.