510(k) K082414 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
OPTIFLUX F250NR, MODEL 0500325E
| Applicant | Fresenius Medical Care North America, Waltham MA, US |
| Decision | Substantially Equivalent, Oct 28, 2008 |
| Received | Aug 21, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082414
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2014 | Fresenius Medical Care Holdings, Inc. Optiflux B200 Flux Dialyzers; Product Number: 0500325E.
Single Use acute or chronic hemanalysis treatment. Terminated |
KDI | None listed |
| Jan 20, 2012 | Fresenius Medical Care Holdings, Inc. Fresenius Optiflux F250NRe Hemodialyzer, , intended for single use in acute and chronic hemodialysis
Catalog No. 0500325E
The Fresenius Optiflux F250NRe Hemodialyzers are intended for patients with a Terminated |
KDI | None listed |
| Mar 22, 2011 | Fresenius Medical Care Holdings, Inc. Fresenius Optiflux F250NRe Hemodialyzer, Single Use, Catalog Number: 0500325E, Advanced Fresenius Polysulfone.
Intended for use as an artificial kidney system to the treatment of patients with renal Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.