Device |
normothermic machine perfusion system for the preservation of donor livers prior to transplantation |
Definition |
The device is intended for machine preservation of donor livers prior to transplantation. |
Physical State |
Device consists of a system made up of several components, such as an oxygenator, thermal control unit, a flow pump, as well as dedicated disposable sets, cannulation accessories, and organ chamber. Bile salts are included with the device. |
Technical Method |
Device actively perfuses the donor liver with a preservation solution, while also oxygenating it, collecting bile and maintaining it in near-physiologic temperatures, so that it may be preserved and assessed for transplantation. |
Target Area |
Donor livers |
Review Panel |
Gastroenterology/Urology |
Product Code | QQK |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
Submission Type |
PMA
|
Device Class |
3
|
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 |
|
|