Definition: These Device Types Do Not Include Devices Whose Primary Purpose Is To Minimize The Incidence Or Severity Of Adhesion Formation As A Result Of Vascular Surgery. Intended To Protect Vessels From Injury During Surgery (not To Be Confused With Wraps, Pat
| Device Type ID | 952 |
| Device Name | Vessel Guard Or Cover |
| Physical State | A 2-dimensional Material |
| Technical Method | The Material Is Cut To Size, Then Laid Over A Blood Vessel And Sutured/tacked Into Nearby Tissue To Keep It From Migrating |
| Target Area | Over A Blood Vessel, Typically The Aorta During Anterior Vertebral Surgery |
| 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 | OMR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 952 |
| Device | Vessel Guard Or Cover |
| Product Code | OMR |
| 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 [🔎] |