510(k) K223905 · QUO Adjunctive Heart Failure Status Indicator
Vivio® LVEDP System
| Applicant | Avicena, LLC, Pasadena CA, US |
| Decision | Substantially Equivalent, Oct 6, 2023 |
| Received | Dec 28, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223905
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.