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 |