510(k) K080964 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
| Applicant | Fresenius Medical Care North America, Waltham MA, US |
| Decision | Substantially Equivalent, Jan 14, 2009 |
| Received | Apr 4, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080964
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2018 | Fresenius Medical Care Renal Therapies Group, LLC 2008T, Hemodialysis Delivery System
Product Indicated for acute and chronic dialysis therapy. Terminated |
KDI | None listed |
| Apr 5, 2016 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home:
Models:
Fresenius 2008K and 2008K2 Dialysate Delivery System
Fresenius 2008K@home Hemodialysis Machine with b Terminated |
KDI | None listed |
| Apr 29, 2015 | Fresenius Medical Care Holdings, Inc. 2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. - Canada;
190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K Terminated |
KDI | None listed |
| Jul 11, 2013 | Fresenius Medical Care Holdings, Inc. Fresenius Service Replacement 0-Ring.
Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.