510(k) K231096 ยท KPM Shunt, Peritoneal
Automatic Continuous Effusion Shunt (ACES) System ACES System
| Applicant | Pleural Dynamics, Inc., Wayzata MN, US |
| Decision | Substantially Equivalent, Aug 18, 2023 |
| Received | Apr 18, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231096
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.