| Device |
ultrafiltration-controlled nocturnal dialysate delivery system |
| Regulation Description |
High permeability hemodialysis system. |
| 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 permeability hemodialyzer and an ultrafiltration-controlled 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 Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | ODN |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
876.5860
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
Yes
|
|---|
| Third Party Review |
Not Third Party Eligible |
