XenoSure Dura Biologic Patch— 510(k) K183513

Substantially Equivalent

LeMaitre Vascular, Inc.

FDA 510(k) clearance K183513 for XenoSure Dura Biologic Patch, Substantially Equivalent on 2019-06-13. Applicant: LeMaitre Vascular, Inc..

Clearance details

Applicant: LeMaitre Vascular, Inc.
Product code: Code GXQ
Advisory panel: Neurology
Date received: 2018-12-18
Decision date: 2019-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GXQ

product code GXQ

Death: 11
Injury: 446
Other: 1
Total: 458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.