| Device Type ID | 790 |
| Device Name | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Regulation Description | Cardiopulmonary Bypass Arterial 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 | 870.4260 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DTM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 790 |
| Device | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Product Code | DTM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiopulmonary Bypass Arterial Line Blood Filter. |
| CFR Regulation Number | 870.4260 [🔎] |
| Device Problems | |
|---|---|
Fluid Leak | 24 |
Leak / Splash | 23 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 5 |
Infusion Or Flow Problem | 3 |
Fracture | 2 |
Particulates | 2 |
Filtration Problem | 2 |
Device Damaged Prior To Use | 2 |
Free Or Unrestricted Flow | 1 |
Break | 1 |
Component(s), Broken | 1 |
Crack | 1 |
Device Expiration Issue | 1 |
Pressure Problem | 1 |
Device Handling Problem | 1 |
Use Of Device Problem | 1 |
Occlusion Within Device | 1 |
Increase In Pressure | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 74 |