# Vessel Guard Or Cover
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 10
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OMR)
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