| Device Type ID | 725 |
| Device Name | 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 |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.4100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BYS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 725 |
| Device | Oxygenator, Long Term Support Greater Than 6 Hours |
| Product Code | BYS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Extracorporeal Circuit And Accessories For Long-term Respiratory/cardiopulmonary Failure. |
| CFR Regulation Number | 870.4100 [🔎] |