| Device Type ID | 838 |
| Device Name | Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass |
| Regulation Description | Cardiopulmonary Bypass Cardiotomy Suction Line Blood Filter. |
| 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 | 870.4270 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JOD |
| 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 | 838 |
| Device | Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass |
| Product Code | JOD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiopulmonary Bypass Cardiotomy Suction Line Blood Filter. |
| CFR Regulation Number | 870.4270 [🔎] |
| Device Problems | |
|---|---|
Fluid Leak | 1 |
Detachment Of Device Or Device Component | 1 |
| Total Device Problems | 2 |