510(k) K071263 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, Aug 24, 2007 |
| Received | May 7, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071263
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2018 | NxStage Medical, Inc. NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A)
Product Usage:
The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prio Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.