| Device Type ID | 803 |
| Device Name | Suction Control, Intracardiac, Cardiopulmonary Bypass |
| Regulation Description | Cardiopulmonary Bypass Intracardiac Suction 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 | 870.4430 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DWD |
| 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 | 803 |
| Device | Suction Control, Intracardiac, Cardiopulmonary Bypass |
| Product Code | DWD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiopulmonary Bypass Intracardiac Suction Control. |
| CFR Regulation Number | 870.4430 [🔎] |
| Device Problems | |
|---|---|
No Apparent Adverse Event | 10 |
Leak / Splash | 2 |
Pressure Problem | 1 |
Detachment Of Device Component | 1 |
Hole In Material | 1 |
Restricted Flow Rate | 1 |
Detachment Of Device Or Device Component | 1 |
Loss Of Or Failure To Bond | 1 |
Suction Problem | 1 |
Delivered As Unsterile Product | 1 |
Connection Problem | 1 |
Valve | 1 |
Contamination During Use | 1 |
| Total Device Problems | 23 |