Panels › Gastroenterology, Urology › Product code FII · Class 2
System, Dialysate Delivery, Sealed
Regulation 876.5860
0510(k)s in 12 months (5 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in FII
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Renal Div | 0 | 2 |
| Gambro, Inc. | 2 | 0 |
| Hospal Medical Corp. | 1 | 0 |
| Nxstage Medical, Inc. | 1 | 0 |
| Travenol Laboratories, S.A. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 24, 2004 | Baxter Healthcare Renal Div System 1000 family of Hemodialysis Instruments, including the System 1000, Arena, 1550, BM11, BM25 and Meridian; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. Terminated |
FII | K030099 K872364 +2 |
| Jul 20, 2004 | Baxter Healthcare Renal Div Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Cor Terminated |
FII | K970446 |
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