510(k) K233691 ยท DYB Introducer, Catheter
FlexCath Cross Transseptal Solution
| Applicant | Acutus Medical, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Dec 17, 2023 |
| Received | Nov 16, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233691
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.