K183513 is an FDA 510(k) clearance for the XenoSure Dura Biologic Patch. This device is classified as a Dura Substitute (Class II - Special Controls, product code GXQ).
Submitted by LeMaitre Vascular, Inc. (Burlington, US). The FDA issued a Cleared decision on June 13, 2019, 177 days after receiving the submission on December 18, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5910.
| 510(k) Number | K183513 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 2018 |
| Decision Date | June 13, 2019 |
| Days to Decision | 177 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXQ — Dura Substitute |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5910 |