Product code OMR

Device name: Vessel Guard Or Cover
Medical specialty: Cardiovascular
Device class: 2
Regulation number: 870.3470
Review panel: CV
Implant: Y
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
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.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K111048	SYNTHES SCOUT TACK FIXATION	Synthes Spine	2012-06-14
K111137	HYDROFIX VASO SHIELD	Mimedx Group, Inc.	2011-05-20
K101805	HYDROFIX VASO SHIELD	Mimedx Group, Inc.	2011-04-08
K103558	SYNTHES SCOUT VESSEL GUARD	Synthes Spine	2011-02-18
K101826	HYDROFIX VASO SHIELD, MODEL HVS-001-0610	Mimedx Group, Inc.	2010-07-28
K100984	XYLOS VESSEL GUARD	Xylos Corporation	2010-07-07
K100905	HYDROFIX SURGICAL SHEET	Mimedx Group, Inc.	2010-06-02
K093551	PARADIS VASO SHIELD	Spinemedica, LLC	2009-12-24
K090022	PARADIS VASO SHIELD	Spinemedica, LLC	2009-04-20
K082782	REPLICATION MEDICAL VESSEL GUARD	Replication Medical, Inc.	2009-04-02

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
D132MG0010	Oral-B Nighttime Dental Guard	Oralabs, LLC	2023-08-04
10705034753799	SCOUT	SYNTHES (U.S.A.) LP	2015-09-14
10705034753805	SCOUT	SYNTHES (U.S.A.) LP	2015-09-14
H98108650101S0	SCOUT	SYNTHES (U.S.A.) LP	2015-09-14
H98108650102S0	SCOUT	SYNTHES (U.S.A.) LP	2015-09-14

Related 510(k) Records#