510(k) K133547 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
NXSTAGE SYSTEM ONE WITH NXVIEW
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, Mar 3, 2014 |
| Received | Nov 19, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133547
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2015 | NxStage Medical, Inc. NxStage System One S Cycler (High Permeability Hemodialysis System)
Model no. NX1000-5 Terminated |
KDI | None listed |
| Oct 29, 2015 | NxStage Medical, Inc. NxStage System One S Cycler (High Permeability Hemodialysis System)
Model no. NX1000-5-A Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.