Vessel Guard Or Cover
The Vessel Guard or Cover (product code OMR) is a Class 2 implantable cardiovascular device regulated under 21 CFR 870.3470 in the Cardiovascular specialty (CV), cleared via 510(k). It is intended to wrap, patch, or cover blood vessels to protect them from surgical injury, and is distinct from devices primarily designed to minimize adhesion formation or to facilitate revision surgeries. The device is flagged as an implant and is not life-sustaining.
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Basic Information
- Product Code
- OMR
- Device Class
- FDA class 2
- Regulation Number
- 870.3470
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K111048 | SYNTHES SCOUT TACK FIXATION | Jun 14, 2012 | Unknown | Synthes Spine |
| K111137 | HYDROFIX VASO SHIELD | May 20, 2011 | Unknown | Mimedx Group, Inc. |
| K101805 | HYDROFIX VASO SHIELD | Apr 08, 2011 | Unknown | Mimedx Group, Inc. |
| K103558 | SYNTHES SCOUT VESSEL GUARD | Feb 18, 2011 | Unknown | Synthes Spine |
| K101826 | HYDROFIX VASO SHIELD, MODEL HVS-001-0610 | Jul 28, 2010 | Unknown | Mimedx Group, Inc. |
| K100984 | XYLOS VESSEL GUARD | Jul 07, 2010 | Unknown | Xylos Corporation |
| K100905 | HYDROFIX SURGICAL SHEET | Jun 02, 2010 | Substantially Equivalent | Mimedx Group, Inc. |
| K093551 | PARADIS VASO SHIELD | Dec 24, 2009 | Unknown | Spinemedica, LLC |
| K090022 | PARADIS VASO SHIELD | Apr 20, 2009 | Unknown | Spinemedica, LLC |
| K082782 | REPLICATION MEDICAL VESSEL GUARD | Apr 02, 2009 | Unknown | Replication Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.