System, Dialysate Delivery, Sealed
FDA product code FII · Class II (moderate risk) · 21 CFR 876.5860 · Gastroenterology, Urology
5510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K030470 | Nxstage System OneFII · Traditional | Nxstage Medical, Inc. | 07/07/2003SE |
| K881270 | Gambro Multipurpose System MPS-10FII · Traditional | Gambro, Inc. | 08/24/1988SE |
| K872364 | Hemodialysis (SPS), Model 550, Code 5M1309FII · Traditional | Travenol Laboratories, S.A. | 10/13/1987SE |
| K862716 | Hemofiltration System 10FII · Traditional | Gambro, Inc. | 09/09/1986SE |
| K822386 | Cotral I W/4.5 L/Hr. Ultrafiltrat. CapaFII · Traditional | Hospal Medical Corp. | 10/06/1982SE |