OMR · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.3470
Classification
FDA Product Code
OMR
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.3470
Review panel
CV
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.