510(k) K003498 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
FRESENIUS OPTIFLUX 200A
| Applicant | Fresenius Medical Care North America, Lexington MA, US |
| Decision | Substantially Equivalent, Jan 4, 2001 |
| Received | Nov 13, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K003498
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2014 | Fresenius Medical Care Holdings, Inc. Optiflux F200A High Flux Dialyzers; Product Number: 0500320A.
Single Use acute or chronic hemanalysis treatment. Terminated |
KDI | None listed |
| Mar 30, 2012 | Fresenius Medical Care Holdings, Inc. Fresenius Optiflux F160NRe Hemodialyzer
Catalog number: 0500316E
Intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.