Device |
temporary non-roller type right heart support blood pump |
Definition |
Providing temporary partial or full right heart circulatory support. |
Physical State |
Rotor or axial type pump manufactured of various materials. Single use, disposable. |
Technical Method |
Assists with partial or full right heart blood circulation either during an adjunctive procedure where the patient requires hemodynamic stability, or a temporary use of the device to unload the right heart to give it time to recover from an acute condition. |
Target Area |
Heart. |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | PYX |
Premarket Review |
Circulatory Support, Structural and Vascular Devices
(DHT2B)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
Submission Type |
PMA
|
Regulation Number |
870.4360
|
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 |