510(k) K002277 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
FRESENIUS OPTIFLUX 200NR
| Applicant | Fresenius Medical Care North America, Lexington MA, US |
| Decision | Substantially Equivalent, Aug 25, 2000 |
| Received | Jul 26, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002277
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2014 | Fresenius Medical Care Holdings, Inc. Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N.
Single Use acute or chronic hemanalysis treatment. Terminated |
KDI | None listed |
| Feb 26, 2014 | Fresenius Medical Care Holdings, Inc. Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N.
Single Use acute or chronic hemanalysis treatment. Terminated |
KDI | None listed |
| Feb 26, 2014 | Fresenius Medical Care Holdings, Inc. Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N.
Single Use acute or chronic hemanalysis treatment. Terminated |
KDI | None listed |
| Jul 1, 2010 | Fresenius Medical Care North America Optiflux F180NR Dialyzers, Catalog Number: 0500318E. Manufactured by Fresenius Medical Care North America, Ogden, UT 84404.
Designed for single use acute and chronic hemodialysis. Terminated |
KDI | None listed |
| Feb 1, 2008 | Fresenius Medical Care North America Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America, Waltham, MA 02451. (Hemodialyzer) Terminated |
KDI | None listed |
| Dec 31, 2005 | Fresenius Medical Care North America Optiflux Series Fresenius Polysulfone F160NR dialyzer High Flux
Catalog Number: 0500316N Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.