Device |
oxygenator, long term support greater than 6 hours |
Regulation Description |
Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure. |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | BYS |
Premarket Review |
Circulatory Support, Structural and Vascular Devices
(DHT2B)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
Submission Type |
510(k)
|
Regulation Number |
870.4100
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
Yes
|
Recognized Consensus Standard
|
Third Party Review |
Not Third Party Eligible |
|
|