OMR

Vessel Guard Or Cover

Product code

OMR

Device name

Vessel Guard Or Cover

Device class

Class 2

21 CFR

21 CFR 870.3470

Medical specialty

Cardiovascular

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (all years, FDA)

10 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).