510(k) K002761 ยท FJI Dialyzer, Capillary, Hollow Fiber
FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS
| Applicant | Fresenius Medical Care North America, Lexington MA, US |
| Decision | Substantially Equivalent, Dec 4, 2000 |
| Received | Sep 5, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002761
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2014 | Fresenius Medical Care Holdings, Inc. Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E.
Single Use acute or chronic hemanalysis treatment. Terminated |
KDI | None listed |
| Feb 26, 2014 | Fresenius Medical Care Holdings, Inc. Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E.
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.