| Device |
vessel guard or cover, to facilitate revision surgeries |
| Regulation Description |
Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene. |
| 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. |
| Product Code | MFX |
| Regulation Number |
870.3470
|
| Device Class |
2
|
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