HYDROFIX VASO SHIELD, MODEL HVS-001-0610
Device Facts
| Record ID | K101826 |
|---|---|
| Device Name | HYDROFIX VASO SHIELD, MODEL HVS-001-0610 |
| Applicant | Mimedx Group, Inc. |
| Product Code | OMR · Cardiovascular |
| Decision Date | Jul 28, 2010 |
| Decision | SESU |
| Submission Type | Special |
| Regulation | 21 CFR 870.3470 |
| Device Class | Class 2 |
Regulatory Classification
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.
