510(k) K070049 ยท ONW Hemodialysis System For Home Use
FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR
| Applicant | Fresenius Medical Care North America, Waltham MA, US |
| Decision | Substantially Equivalent, Feb 3, 2011 |
| Received | Jan 4, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070049
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2015 | Fresenius Medical Care Holdings, Inc. 2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYST Terminated |
KDI | None listed |
| Jan 6, 2014 | Fresenius Medical Care Holdings, Inc. Fresenius 2008 Series Hemodialysis Machines:
Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T
The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. Hemodialysis is indica Terminated |
KDI | None listed |
| Nov 8, 2013 | Fresenius Medical Care Holdings, Inc. 2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use
Catalog Number: 03-2962-3.
Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use wit Terminated |
ONW | None listed |
| Nov 8, 2013 | Fresenius Medical Care Holdings, Inc. Combiset Blood Line with BVM for Hemodialysis use
Catalog Number: 03-2965-9.
Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and hi Terminated |
ONW | None listed |
| Nov 8, 2013 | Fresenius Medical Care Holdings, Inc. Combiset Blood Line Hemodialysis use
Catalog Number: 03-2622-3.
Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux nega Terminated |
ONW | None listed |
| Sep 20, 2011 | Fresenius Medical Care Holdings, Inc. CombiSet True Flow" 2008K@home Bloodlines
Fresenius Medical Care.
Used for transferring blood during the hemodialysis treatment from the patient to the dialyzer (artificial kidney), removing extra wa Terminated |
ODX | None listed |
| Aug 29, 2011 | Fresenius Medical Care Holdings, Inc. Fresenius 2008K@home
The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and mu Terminated |
ONW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.