| Device Type ID | 868 |
| Device Name | Graft, Vascular, Synthetic/biologic Composite |
| Regulation Description | Vascular Graft Prosthesis. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Vascular Surgery Devices Branch (VSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.3450 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MAL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 868 |
| Device | Graft, Vascular, Synthetic/biologic Composite |
| Product Code | MAL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Vascular Graft Prosthesis. |
| CFR Regulation Number | 870.3450 [🔎] |
| Device Problems | |
|---|---|
Leak / Splash | 19 |
Manufacturing, Packaging Or Shipping Problem | 12 |
Hole In Material | 8 |
Material Integrity Problem | 5 |
Material Frayed | 5 |
Material Puncture / Hole | 4 |
Device Packaging Compromised | 4 |
Fluid Leak | 4 |
Insufficient Information | 3 |
Unraveled Material | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Appropriate Term/Code Not Available | 2 |
Material Discolored | 2 |
Product Quality Problem | 2 |
Material Twisted / Bent | 2 |
Incomplete Or Missing Packaging | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Device Contaminated During Manufacture Or Shipping | 1 |
Material Deformation | 1 |
Peeled / Delaminated | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Device Issue | 1 |
Out-Of-Box Failure | 1 |
Material Perforation | 1 |
Packaging Problem | 1 |
Device Operates Differently Than Expected | 1 |
Device Operational Issue | 1 |
Human-Device Interface Problem | 1 |
Physical Property Issue | 1 |
Label | 1 |
| Total Device Problems | 95 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Vascutek, Ltd. | II | Jun-26-2015 |