510(k) K042045 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
NXSTAGE PUREFLOW-B SOLUTION
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, Aug 27, 2004 |
| Received | Jul 30, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042045
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 2, 2013 | NxStage Medical, Inc. NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case
The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premix Terminated |
KPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.