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 |