| Device Type ID | 1039 |
| Device Name | Glue, Surgical, Arteries |
| 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 | MUQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1039 |
| Device | Glue, Surgical, Arteries |
| Product Code | MUQ |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 101 |
Appropriate Term/Code Not Available | 13 |
Insufficient Information | 5 |
Failure To Adhere Or Bond | 3 |
Device Operates Differently Than Expected | 2 |
Migration Or Expulsion Of Device | 1 |
Patient-Device Incompatibility | 1 |
Contamination During Use | 1 |
Use Of Device Problem | 1 |
Complete Blockage | 1 |
Material Fragmentation | 1 |
Plunger | 1 |
| Total Device Problems | 131 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | CryoLife, Inc. | II | Jul-26-2018 |
| 2 | CryoLife, Inc. | II | Jun-23-2017 |
| 3 | CryoLife, Inc. | II | May-30-2014 |