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 |