OMR · Vessel Guard Or Cover
Cardiovascular · 21 CFR 870.3470 · Class 2
Overview
| Product Code | OMR |
|---|---|
| Device Name | Vessel Guard Or Cover |
| Regulation | 21 CFR 870.3470 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Implant | Yes |
Identification
An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K111048 | SYNTHES SCOUT TACK FIXATION | Synthes Spine | Jun 14, 2012 | SESU |
| K111137 | HYDROFIX VASO SHIELD | Mimedx Group, Inc. | May 20, 2011 | SESU |
| K101805 | HYDROFIX VASO SHIELD | Mimedx Group, Inc. | Apr 8, 2011 | SESU |
| K103558 | SYNTHES SCOUT VESSEL GUARD | Synthes Spine | Feb 18, 2011 | SESU |
| K101826 | HYDROFIX VASO SHIELD, MODEL HVS-001-0610 | Mimedx Group, Inc. | Jul 28, 2010 | SESU |
| K100984 | XYLOS VESSEL GUARD | Xylos Corporation | Jul 7, 2010 | SESU |
| K100905 | HYDROFIX SURGICAL SHEET | Mimedx Group, Inc. | Jun 2, 2010 | SESE |
| K093551 | PARADIS VASO SHIELD | Spinemedica, LLC | Dec 24, 2009 | SESU |
| K090022 | PARADIS VASO SHIELD | Spinemedica, LLC | Apr 20, 2009 | SESU |
| K082782 | REPLICATION MEDICAL VESSEL GUARD | Replication Medical, Inc. | Apr 2, 2009 | SESU |
Top Applicants
- Mimedx Group, Inc. — 4 clearances
- Spinemedica, LLC — 2 clearances
- Synthes Spine — 2 clearances
- Replication Medical, Inc. — 1 clearance
- Xylos Corporation — 1 clearance
