OMR
10 FDA 510(k) clearances · Product code
90 daysmedian time to decision
426 days90th percentile
10clearances measured
FDA profile
- Official device name
- Vessel Guard Or Cover
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3470
- Medical specialty
- Cardiovascular
- Flags
- Implant
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SYNTHES SCOUT TACK FIXATION (K111048) | Synthes Spine | 2012-06-14 |
| HYDROFIX VASO SHIELD (K111137) | Mimedx Group, Inc. | 2011-05-20 |
| HYDROFIX VASO SHIELD (K101805) | Mimedx Group, Inc. | 2011-04-08 |
| SYNTHES SCOUT VESSEL GUARD (K103558) | Synthes Spine | 2011-02-18 |
| HYDROFIX VASO SHIELD, MODEL HVS-001-0610 (K101826) | Mimedx Group, Inc. | 2010-07-28 |
| XYLOS VESSEL GUARD (K100984) | Xylos Corporation | 2010-07-07 |
| HYDROFIX SURGICAL SHEET (K100905) | Mimedx Group, Inc. | 2010-06-02 |
| PARADIS VASO SHIELD (K093551) | Spinemedica, LLC | 2009-12-24 |
| PARADIS VASO SHIELD (K090022) | Spinemedica, LLC | 2009-04-20 |
| REPLICATION MEDICAL VESSEL GUARD (K082782) | Replication Medical, Inc. | 2009-04-02 |
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Every clearance here is in the API, with alerts when new ones post.