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 |