510(k) K100799 ยท DYB Introducer, Catheter
FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815
| Applicant | Contract Medical Intl. GmbH, Dresden, Sachsen, DE |
| Decision | Substantially Equivalent, Feb 25, 2011 |
| Received | Mar 22, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100799
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.