Device |
organ care system (ocs) heart system |
Definition |
A portable ex vivo organ perfusion system used to preserve a donor heart for transplantation into a potential recipient. |
Physical State |
Device includes a perfusion apparatus and may also include a preservation solution set as part of the system. The perfusion apparatus consists of an enclosure that houses the hardware and software used to control and perform functions such as perfusion, gas exchange, and temperature regulation. |
Technical Method |
Device actively perfuses the donor hearts with a preservation solution at a normothermic or hypothermic temperature throughout the preservation period. |
Target Area |
Donor heart |
Review Panel |
Cardiovascular |
Product Code | QIK |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
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 |