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.
Leading manufacturers include Synthes Spine, Replication Medical, Inc. and Mimedx Group, Inc..
10
Total
10
Cleared
133d
Avg days
2009
Since
FDA 510(k) Cleared Vessel Guard Or Cover Devices (Product Code OMR)
10 devices
Cleared
Jun 14, 2012
SYNTHES SCOUT TACK FIXATION
Synthes Spine
Orthopedic
426d
Cleared
May 20, 2011
HYDROFIX VASO SHIELD
Mimedx Group, Inc.
Cardiovascular
28d
Cleared
Feb 18, 2011
SYNTHES SCOUT VESSEL GUARD
Synthes Spine
Cardiovascular
78d
Cleared
Apr 02, 2009
REPLICATION MEDICAL VESSEL GUARD
Replication Medical, Inc.
Cardiovascular
192d