Cleared Traditional

XenoSure Dura Biologic Patch

K183513 · LeMaitre Vascular, Inc. · Neurology
Jun 2019
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K183513 is an FDA 510(k) clearance for the XenoSure Dura Biologic Patch, 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 review panel. Regulated under 21 CFR 882.5910.

Submission Details

510(k) Number K183513 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code GXQ — Dura Substitute
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5910

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