K881732 is an FDA 510(k) clearance for the GORE-TEX VASCULAR GRAFT. This device is classified as a Prosthesis, Vascular Graft, Of Less Then 6mm Diameter (Class II - Special Controls, product code DYF).
Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on May 18, 1988, 26 days after receiving the submission on April 22, 1988.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K881732 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 1988 |
| Decision Date | May 18, 1988 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DYF — Prosthesis, Vascular Graft, Of Less Then 6mm Diameter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3450 |