GORE-TEX TUNNELER
Device Facts
| Record ID | K844584 |
|---|---|
| Device Name | GORE-TEX TUNNELER |
| Applicant | W. L. Gore & Associates, Inc. |
| Product Code | DWS · Cardiovascular |
| Decision Date | Jan 24, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4500 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.
