510(k) K181463 ยท DYB Introducer, Catheter
DuraSheath Introducer Sheath System
| Applicant | Contract Medical International, GmbH, Dresden, DE |
| Decision | Substantially Equivalent, Dec 13, 2018 |
| Received | Jun 4, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181463
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.