| Device Type ID | 796 |
| Device Name | Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass |
| Regulation Description | Cardiopulmonary Bypass Level Sensing Monitor And/or Control. |
| 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) Exempt |
| CFR Regulation Number | 870.4340 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DTW |
| 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 | 796 |
| Device | Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass |
| Product Code | DTW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiopulmonary Bypass Level Sensing Monitor And/or Control. |
| CFR Regulation Number | 870.4340 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MEDTRONIC, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Operational Issue | 15 |
False Alarm | 7 |
Device Alarm System | 7 |
Device Displays Incorrect Message | 5 |
Sensor | 4 |
Monitor | 4 |
Break | 3 |
Pumping Stopped | 3 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 3 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Delayed Alarm | 2 |
Failure To Power Up | 2 |
No Display / Image | 2 |
Failure To Calibrate | 1 |
Failure To Auto Stop | 1 |
No Flow | 1 |
Connection Problem | 1 |
Latch | 1 |
Bubble Detector | 1 |
Circuit Board | 1 |
False Reading From Device Non-Compliance | 1 |
Failure To Sense | 1 |
Communication Or Transmission Problem | 1 |
Device Operates Differently Than Expected | 1 |
Pressure Problem | 1 |
Temperature Probe | 1 |
No Device Output | 1 |
Alarm, Audible | 1 |
Connector | 1 |
| Total Device Problems | 75 |