510(k) K121341 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM
| Applicant | Fresenius Medical Care North America, Waltham MA, US |
| Decision | Substantially Equivalent, Dec 6, 2012 |
| Received | May 3, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121341
| 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 |
| Jan 27, 2015 | Fresenius Medical Care Holdings, Inc. ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment
2008K@home Terminated |
KDI | None listed |
| May 13, 2014 | Fresenius Medical Care Holdings, Inc. Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 20 Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.