Definition: For Temporarily Occluding Vessels During Anastomosis Procedures.
| Device Type ID | 1064 |
| Device Name | Occluder, Internal Vessel, Temporary |
| Physical State | Liquid At Room Temperature And Gel At Body Temperature |
| Technical Method | The Material Is Thermosensitive Such That It Forms A Gel When Injected Into The Blood Vessel, And Remains Gelled For The Period It Takes To Make The Anastomosis |
| Target Area | Blood Vessels |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Structural Heart Devices Branch (SHDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OBC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1064 |
| Device | Occluder, Internal Vessel, Temporary |
| Product Code | OBC |
| FDA Device Classification | Class 3 Medical Device |