Device |
hemodialysis system for home use |
Regulation Description |
High permeability hemodialysis system. |
Definition |
To treat and provide hemodialysis therapy at home for chronic renal failure patients. |
Physical State |
Complex machine consisting of pumps, monitors, and tubing. |
Technical Method |
A machine that dialyzes the patient's blood. |
Target Area |
Connects to the patient's blood stream |
Regulation Medical Specialty |
Gastroenterology/Urology |
Review Panel |
Gastroenterology/Urology |
Product Code | ONW |
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? |
No
|
Third Party Review |
Not Third Party Eligible |