| Device Type ID | 797 |
| Device Name | Gas Control Unit, Cardiopulmonary Bypass |
| Regulation Description | Cardiopulmonary Bypass Gas Control Unit. |
| 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 | 870.4300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DTX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 797 |
| Device | Gas Control Unit, Cardiopulmonary Bypass |
| Product Code | DTX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiopulmonary Bypass Gas Control Unit. |
| CFR Regulation Number | 870.4300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SPECTRUM | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPECTRUM MEDICAL LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Displays Incorrect Message | 55 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 29 |
Appropriate Term/Code Not Available | 18 |
Device Operates Differently Than Expected | 9 |
Improper Flow Or Infusion | 8 |
Insufficient Flow Or Under Infusion | 6 |
Inaccurate Flow Rate | 6 |
No Flow | 5 |
Alarm, Audible | 5 |
Device Alarm System | 4 |
Alarm | 4 |
Use Of Device Problem | 4 |
Infusion Or Flow Problem | 4 |
Device Operational Issue | 3 |
Incorrect Measurement | 3 |
Erratic Or Intermittent Display | 3 |
Output Problem | 3 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 3 |
Display Or Visual Feedback Problem | 2 |
Gas Output Problem | 2 |
No Display / Image | 1 |
Failure To Deliver | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Output Above Specifications | 1 |
Gas Leak | 1 |
Defective Component | 1 |
Alarm, Visual | 1 |
Calibration Problem | 1 |
Failure To Shut Off | 1 |
Alarm Not Visible | 1 |
Leak / Splash | 1 |
Air Leak | 1 |
Loss Of Power | 1 |
Device Issue | 1 |
Device Handling Problem | 1 |
| Total Device Problems | 191 |