Definition: Hemodialysis Performed With A High Permeability Hemodialyzer And An Ultrafiltration-controlled System. Nocturnal Hemodialysis For Patients With End-stage Renal Disease (chronic Dialysis) Or Acute Renal Failure (acute Dialysis) Performed With A High P
| Device Type ID | 2075 |
| Device Name | Ultrafiltration-controlled Nocturnal Dialysate Delivery System |
| Physical State | Device Is An Electronic, Software-controlled System With A User Interface. Device Can Include Extracorporeal Tubing Sets, But Not Necessarily. |
| Technical Method | Device Consists Of A System Of Pumps, Valves, Sensors, Monitors And Other Components That Direct Blood Through A Dialyzer So That Hemodialysis May Be Performed. |
| Target Area | Device Is An Extracorporeal Device Treating Patients' Blood. |
| Regulation Description | High Permeability Hemodialysis System. |
| 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 | 876.5860 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ODN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2075 |
| Device | Ultrafiltration-controlled Nocturnal Dialysate Delivery System |
| Product Code | ODN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | High Permeability Hemodialysis System. |
| CFR Regulation Number | 876.5860 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
NXSTAGE MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NXSTAGE MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |