510(k) K043244 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR
| Applicant | Fresenius Medical Care North America, Lexington MA, US |
| Decision | Substantially Equivalent, Dec 20, 2004 |
| Received | Nov 23, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043244
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2014 | Fresenius Medical Care Holdings, Inc. Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E.
Single Use acute or chronic hemanalysis treatment. Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.