Device |
oxygenator, cardiopulmonary bypass |
Regulation Description |
Cardiopulmonary bypass oxygenator. |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | DTZ |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
Submission Type |
510(k)
|
Regulation Number |
870.4350
|
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 Standards
|
Guidance Documents
|
Third Party Review |
Not Third Party Eligible |