OMRClass II

Vessel Guard Or Cover

21 CFR 870.3470 / Cardiovascular

OMR is the FDA product code for Vessel Guard Or Cover, a class II device type, regulated under 21 CFR 870.3470. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 10 510(k) clearances under this code, the most recent dated 2012-06-14, and no recalls.

Classification record

Product code: OMR
Device name: Vessel Guard Or Cover
FDA 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.
Regulation: 21 CFR 870.3470
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 10
Ingested recalls: 0

Clearances, product code OMR

By decision year

10 clearances under product code OMR with a decision year between 2009 and 2012, 2009 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code OMR by decision year
Year	Clearances
2009	3
2010	3
2011	3
2012	1

Applicants with the most clearances

Product code OMR

Applicants holding the most 510(k) clearances under product code OMR
Applicant	Clearances
Mimedx Group, Inc.	4
Spinemedica, LLC	2
Synthes GmbH	2
Replication Medical, Inc.	1
Xylos Corporation	1

Companies listing this code with FDA

Companies whose registered establishments list this code