| Device |
temporary cardiac support blood pump |
| Regulation Description |
Nonroller-type cardiopulmonary bypass blood pump. |
| Definition |
Temporary circulatory support < 6 hours of use during off-pump bypass (opcab). |
| Physical State |
A catheter based axial flow impeller pump that is implanted within the heart. the pump unloads the heart by actively pumping blood from the left veitricle to the aorta for durations of 6 hours or less. |
| Technical Method |
The blood pump is used to support the circulation during surgical procedures (lasting < 6 hours) with or without the use of an oxygenator. |
| Target Area |
Intracardiac. |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | PBL |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.4360
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
