GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE
Device Facts
| Record ID | K914448 |
|---|---|
| Device Name | GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE |
| Applicant | W. L. Gore & Associates, Inc. |
| Product Code | DXZ · Cardiovascular |
| Decision Date | Nov 5, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| 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.
