510(k) K040696 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
MODIFICATION TO NXSTAGE SYSTEM ONE
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, May 26, 2004 |
| Received | Mar 17, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040696
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | NxStage Medical, Inc. NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-124, 6 units per case. Terminated |
KDI | None listed |
| Jul 20, 2004 | NxStage Medical, Inc. NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-153 Cartridge Express. 6 units per case. Terminated |
KDI | None listed |
| Jul 20, 2004 | NxStage Medical, Inc. NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model # CAR-154 Cartridge Express, 6 units per case. Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.