510(k) K142357 ยท DYB Introducer, Catheter
DuraSheath Introducer Sheath System
| Applicant | Contract Medical International, GmbH, Dresden, DE |
| Decision | Substantially Equivalent, Jun 25, 2015 |
| Received | Aug 25, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142357
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.