510(k) K061837 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
NXSTAGE CARTRIDGE EXPRESS
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, Jul 31, 2006 |
| Received | Jun 29, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061837
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2007 | NxStage Medical, Inc. NxStage Cartridge Express, CAR-170, for hemodialysis. Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.