510(k) K190644 ยท DYB Introducer, Catheter
Guide Sheath
| Applicant | Surmodics,Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Apr 18, 2019 |
| Received | Mar 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190644
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.