| Device Type ID | 1861 |
| Device Name | System, Dialysate Delivery, Single Pass |
| Regulation Description | Hemodialysis System And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Renal Devices Branch (RNDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5820 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FIL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |