510(k) K122051 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
NXSTAGE SYSTEM ONE
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, Apr 23, 2013 |
| Received | Jul 12, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122051
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2015 | NxStage Medical, Inc. NxStage System One S Cycler - Model no. NX1000-3.
For home hemodialysis. Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.