| Device Type ID | 798 |
| Device Name | Sensor, Blood-gas, In-line, Cardiopulmonary Bypass |
| Regulation Description | Cardiopulmonary Bypass In-line Blood Gas Sensor. |
| 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 | 870.4410 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DTY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 798 |
| Device | Sensor, Blood-gas, In-line, Cardiopulmonary Bypass |
| Product Code | DTY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiopulmonary Bypass In-line Blood Gas Sensor. |
| CFR Regulation Number | 870.4410 [🔎] |
| Device Problems | |
|---|---|
Battery | 6 |
Battery Problem | 3 |
Crack | 3 |
Fluid Leak | 3 |
Incorrect Or Inadequate Test Results | 3 |
Monitor | 2 |
No Display / Image | 2 |
Leak / Splash | 1 |
Clip | 1 |
Break | 1 |
| Total Device Problems | 25 |