510(k) K050525 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
NXSTAGE SYSTEM ONE
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, Jun 24, 2005 |
| Received | Mar 2, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050525
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 27, 2019 | NxStage Medical, Inc. Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices:
1) NxStage One, Model NX1000-1;
2) NxStage VersiHD Cycler, Model Numbers: NX1000-16, and NX1000-16-A;
3) NxStage One, Model N Terminated |
PEV | None listed |
| Sep 20, 2007 | NxStage Medical, Inc. NxStage Cartridge Express, CAR-170, for hemodialysis. Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.