510(k) K171331 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
NxStage System One
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, Aug 24, 2017 |
| Received | May 8, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171331
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.