510(k) K102925 ยท DYB Introducer, Catheter
NEXGEN EXPANDABLE CATHETER
| Applicant | Nexgen Medical Systems, Inc., Melbourne FL, US |
| Decision | Substantially Equivalent, Nov 10, 2011 |
| Received | Oct 4, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102925
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.