| Device Type ID | 1020 |
| Device Name | Tissue Graft Of 6mm And Greater |
| 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 | LXA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1020 |
| Device | Tissue Graft Of 6mm And Greater |
| Product Code | LXA |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Surgical Graft | 28 |
Leak / Splash | 10 |
Material Integrity Problem | 5 |
Obstruction Of Flow | 4 |
Human Factors Issue | 4 |
Hole In Material | 3 |
Device Packaging Compromised | 3 |
Fluid Leak | 3 |
Contamination / Decontamination Problem | 3 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Occlusion Within Device | 2 |
Physical Property Issue | 2 |
Insufficient Information | 2 |
Break | 1 |
Improper Flow Or Infusion | 1 |
Inadequate Or Insufficient Training | 1 |
Device Handling Problem | 1 |
Facilities Issue | 1 |
Bent | 1 |
Human-Device Interface Problem | 1 |
| Total Device Problems | 78 |