Vessel Guard Or Cover
Cardiovascular · 21 CFR 870.3470
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 MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
10 clearances for this product code
- Synthes SpineJun 14, 2012
K111048 · SYNTHES SCOUT TACK FIXATION
- Mimedx Group, Inc.May 20, 2011
K111137 · HYDROFIX VASO SHIELD
- Mimedx Group, Inc.Apr 8, 2011
K101805 · HYDROFIX VASO SHIELD
- Synthes SpineFeb 18, 2011
K103558 · SYNTHES SCOUT VESSEL GUARD
- Mimedx Group, Inc.Jul 28, 2010
K101826 · HYDROFIX VASO SHIELD, MODEL HVS-001-0610
- Xylos CorporationJul 7, 2010
K100984 · XYLOS VESSEL GUARD
- Mimedx Group, Inc.Jun 2, 2010
K100905 · HYDROFIX SURGICAL SHEET
- Spinemedica, LLCDec 24, 2009
K093551 · PARADIS VASO SHIELD