Panels › Gastroenterology, Urology › Product code FKQ · Class 2
System, Dialysate Delivery, Central Multiple Patient
Regulation 876.5820
0510(k)s in 12 months (61 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in FKQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Hospal Medical Corp. | 7 | 0 |
| Travenol Laboratories, S.A. | 5 | 0 |
| Extracorporeal Medical Specialities, Inc. | 4 | 0 |
| National Medical Care, Medical Products Div., Inc. | 4 | 0 |
| Renal Systems, Inc. | 4 | 0 |
| Erika, Inc. | 2 | 0 |
| Organon Teknika Corp. | 2 | 0 |
| Seratronics, Inc. | 2 | 0 |
| Alan P. Kendal, Ph.D. | 1 | 0 |
| Alcide Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2021 | Medivators, Inc. Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine. Terminated |
FKQ | K843963 |
| Apr 26, 2013 | B. Braun Medical, Inc. Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367.
Intended to filter bacteria and endotoxins from dialysis fluid. Terminated |
FKQ | K052764 |
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