OMR · Class II · 21 CFR 870.3470

FDA Product Code OMR: Vessel Guard Or Cover

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.

10
Total
10
Cleared
133d
Avg days
2009
Since

FDA 510(k) Cleared Vessel Guard Or Cover Devices (Product Code OMR)

10 devices
1–10 of 10
No devices found for this product code.

About Product Code OMR - Regulatory Context