510(k) K232803 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, Mar 14, 2024 |
| Received | Sep 12, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232803
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.