K940906 is an FDA 510(k) clearance for the GORE-TEX CARDIOVASCULAR PATCH. This device is classified as a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II - Special Controls, product code DXZ).
Submitted by W.L. Gore & Associates, Inc. (Elkton, US). The FDA issued a Cleared decision on May 18, 1994, 83 days after receiving the submission on February 24, 1994.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3470.
| 510(k) Number | K940906 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 1994 |
| Decision Date | May 18, 1994 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXZ — Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3470 |