510(k) K180081 ยท DYB Introducer, Catheter
RAILWAY Sheathless Access System
| Applicant | Cordis Corporation, Milpitas CA, US |
| Decision | Substantially Equivalent, Apr 18, 2018 |
| Received | Jan 11, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180081
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.