510(k) K140526 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
NXSTAGE SYSTEM ONE
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, May 19, 2014 |
| Received | Mar 4, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140526
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2015 | NxStage Medical, Inc. NxStage System One S Cycler - Model no. NX1000-3-A (OUS).
For home hemodialysis. Terminated |
KDI | None listed |
| Oct 29, 2015 | NxStage Medical, Inc. NxStage System One S Cycler -High Permeability Hemodialysis System
Model no. NX1000-4 Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.