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Vessel Guard Or Cover

FDA product code OMR · 10 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.3470
Review panel
CV
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2009-04-02 – 2012-06-14

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.

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