Panels › Gastroenterology, Urology › Product code ONW · Class 2
Hemodialysis System For Home Use
Regulation 876.5860
0510(k)s in 12 months (4 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in ONW
| Company | 510(k)s | Recalls |
|---|---|---|
| Fresenius Medical Care Holdings, Inc. | 0 | 4 |
| Fresenius Medical Care North America | 2 | 0 |
| Fresenius Medical Care North America, Design Cente | 1 | 0 |
| Quanta Dialysis Technologies, Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K070049 |
| 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 | K070049 |
| 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 | K070049 |
| 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 | K070049 |
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