510(k) K183158 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
NxStage Cartridge Express with Speedswap
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, Aug 9, 2019 |
| Received | Nov 15, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183158
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2024 | NxStage MDS Corporation NxStage Cartridge Express with Speedswap, Catalog No. CAR-535.
An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic rena Open, Classified |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.