The following data is part of a premarket notification filed by Lemaitre Vascular Inc. with the FDA for Xenosure Dura Biologic Patch.
| Device ID | K183513 |
| 510k Number | K183513 |
| Device Name: | XenoSure Dura Biologic Patch |
| Classification | Dura Substitute |
| Applicant | LeMaitre Vascular Inc. 63 Second Ave Burlington, MA 01803 |
| Contact | Xiang Zhang |
| Correspondent | Xiang Zhang LeMaitre Vascular Inc. 63 Second Ave Burlington, MA 01803 |
| Product Code | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-18 |
| Decision Date | 2019-06-13 |