W. L. Gore & Associates, Inc. · Class II · Cleared Nov 5, 1991
| K-number | K914448 |
| Device name | GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE |
| Applicant | W. L. Gore & Associates, Inc. |
| Product code | DXZ |
| Device class | Class II |
| Decision date | Nov 5, 1991 |
| Decision | Substantially Equivalent |
| Regulation | 870.3470 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov