510(k) K152367 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Optiflux dialyzer
| Applicant | Fresenius Medical Care North America, Waltham MA, US |
| Decision | Substantially Equivalent, Oct 29, 2015 |
| Received | Aug 21, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152367
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2018 | Fresenius Medical Care Renal Therapies Group, LLC Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.