FDA 510(k)

XenoSure Dura Biologic Patch

K-Number: K183513 · 2019-06-13

Decision Date2019-06-13

Product CodeGXQ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

XenoSure Dura Biologic Patch is a medical device manufactured by LeMaitre Vascular, Inc.. It received FDA 510(k) clearance on 2019-06-13 under approval number K183513. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XenoSure Dura Biologic Patch?

XenoSure Dura Biologic Patch is a medical device that received FDA 510(k) clearance on 2019-06-13. It is manufactured by LeMaitre Vascular, Inc.. The 510(k) number is K183513.

When was XenoSure Dura Biologic Patch approved by the FDA?

XenoSure Dura Biologic Patch received FDA 510(k) clearance on 2019-06-13, under approval number K183513.

What company makes XenoSure Dura Biologic Patch?

XenoSure Dura Biologic Patch is manufactured by LeMaitre Vascular, Inc..

What is the FDA product code for XenoSure Dura Biologic Patch?

The FDA product code for XenoSure Dura Biologic Patch is GXQ.

Other Devices by LeMaitre Vascular, Inc.

K152833Pruitt F3-S Polyurethane Carotid Shunt K173323AnastoClip GC Closure System K212894PhasTIPP PMA N16837Tissue graft of 6mm and greater PMA P020049Tissue graft of 6mm and greater

Related Devices (Code: GXQ)

K161370Durepair Dura Regeneration MatrixMedtronic Neurosurgery K161278Cerafix Dura SubstituteAcera Surgical, Inc. K153613Cerafix Dura SubstituteAcera Surgical, Inc. K172603Cerafix Dura SubstituteAcera Surgical, Inc. K163456DuraGen Secure Dural Regeneration MatrixIntegra LifeSciences Corporation K212943SyntheCel Dura RepairSynthes (USA) Products, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.