510(k) K143313 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
NxStage Therapeutic Plasma Exchange (TPE) Cartridge
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, Mar 20, 2015 |
| Received | Nov 19, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143313
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.