510(k) K080919 ยท FKR Subsystem, Proportioning
NXSTAGE PUREFLOW SL
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, Oct 15, 2008 |
| Received | Apr 1, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080919
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 20, 2012 | NxStage Medical, Inc. NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx
The NxStage PureFLow SL is an optional accessory to the NxStage System One that prepares dialysate Terminated |
FKR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.