510(k) K161659 ยท DYB Introducer, Catheter
FlexSeal Introducer Sheath with Hydrophilic Coating
| Applicant | Libramedical, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jul 15, 2016 |
| Received | Jun 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161659
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.