OMR — Vessel Guard Or Cover Class II
Classification Details
- Product Code
- OMR
- Device Class
- Class II
- Regulation Number
- 870.3470
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K111048 | synthes spine | SYNTHES SCOUT TACK FIXATION | June 14, 2012 |
| K111137 | mimedx group | HYDROFIX VASO SHIELD | May 20, 2011 |
| K101805 | mimedx group | HYDROFIX VASO SHIELD | April 8, 2011 |
| K103558 | synthes spine | SYNTHES SCOUT VESSEL GUARD | February 18, 2011 |
| K101826 | mimedx group | HYDROFIX VASO SHIELD, MODEL HVS-001-0610 | July 28, 2010 |
| K100984 | xylos corporation | XYLOS VESSEL GUARD | July 7, 2010 |
| K100905 | mimedx group | HYDROFIX SURGICAL SHEET | June 2, 2010 |
| K093551 | spinemedica | PARADIS VASO SHIELD | December 24, 2009 |
| K090022 | spinemedica | PARADIS VASO SHIELD | April 20, 2009 |
| K082782 | replication medical | REPLICATION MEDICAL VESSEL GUARD | April 2, 2009 |