| Device Type ID | 1016 |
| Device Name | Occluder, Balloon, Vena-cava |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Vascular Surgery Devices Branch (VSDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | LWT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1016 |
| Device | Occluder, Balloon, Vena-cava |
| Product Code | LWT |
| FDA Device Classification | Class 3 Medical Device |