| Device Type ID | 859 |
| Device Name | Detector, Bubble, Cardiopulmonary Bypass |
| Regulation Description | Cardiopulmonary Bypass Bubble Detector. |
| 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 | 870.4205 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KRL |
| 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 | 859 |
| Device | Detector, Bubble, Cardiopulmonary Bypass |
| Product Code | KRL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiopulmonary Bypass Bubble Detector. |
| CFR Regulation Number | 870.4205 [🔎] |
| Device Problems | |
|---|---|
False Alarm | 7 |
Device Operational Issue | 5 |
Pumping Stopped | 3 |
Device Alarm System | 2 |
Material Integrity Problem | 2 |
Device Displays Incorrect Message | 2 |
Physical Property Issue | 1 |
Appropriate Term/Code Not Available | 1 |
Bubble Detector | 1 |
Failure To Sense | 1 |
Communication Or Transmission Problem | 1 |
Alarm | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Sensing Intermittently | 1 |
Device Issue | 1 |
| Total Device Problems | 31 |