Definition: Wrap, Patch, Or Cover Intended To Protect Vessels From Injury During Surgery, With The Secondary Function Of Facilitating Revision Surgeries By Providing A Plane Of Dissection.
| Device Type ID | 871 |
| Device Name | Vessel Guard Or Cover, To Facilitate Revision Surgeries |
| Regulation Description | Intracardiac Patch Or Pledget Made Of Polypropylene, Polyethylene Terephthalate, Or Polytetrafluoroethylene. |
| 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 | 870.3470 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MFX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 871 |
| Device | Vessel Guard Or Cover, To Facilitate Revision Surgeries |
| Product Code | MFX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intracardiac Patch Or Pledget Made Of Polypropylene, Polyethylene Terephthalate, Or Polytetrafluoroethylene. |
| CFR Regulation Number | 870.3470 [🔎] |