Device |
vessel guard or cover |
Regulation Description |
Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene. |
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, patches or covers intended to facilitate revision surgeries). Indicated to wrap, patch, or cover intended to cover blood vessels. |
Product Code | OMR |
Regulation Number |
870.3470
|
Device Class |
2
|
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