K821158 is an FDA 510(k) clearance for the FED RINGED-TEX VASCULAR GRAFT. This device is classified as a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II - Special Controls, product code DSY).
Submitted by W.L. Gore & Associates, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 18, 1982, 21 days after receiving the submission on April 27, 1982.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3450.
| 510(k) Number | K821158 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 1982 |
| Decision Date | May 18, 1982 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3450 |