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FDA 510(k)

XenoSure Dura Biologic Patch

K-Number: K183513 · 2019-06-13

ApplicantLeMaitre Vascular, Inc.
Decision Date2019-06-13
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

XenoSure Dura Biologic Patch is the device name listed in this FDA 510(k) record. The listed applicant is LeMaitre Vascular, Inc.. It received FDA 510(k) clearance on 2019-06-13 under 510(k) 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. The listed applicant is LeMaitre Vascular, Inc.. The 510(k) number is K183513.

When did XenoSure Dura Biologic Patch receive FDA 510(k) clearance?

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

Who is the listed applicant for XenoSure Dura Biologic Patch?

The FDA 510(k) record lists LeMaitre Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing LeMaitre Vascular, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA N16837Tissue graft of 6mm and greaterK212894PhasTIPPK190882XenoSure Biologic PatchK190267EZE SIT ValvulotomeK182916Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 FrPMA P020049Tissue graft of 6mm and greater

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Related Devices (Code: GXQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251191Collagen Dura Regeneration Membrane - RepairCollagen Matrix, Inc.K250420Helios Dura Regeneration MatrixHelios Biomedical, Inc.K223445ArtiFasciaNurami Medical , Ltd.K212943SyntheCel Dura RepairSynthes (USA) Products, LLCK172603Cerafix Dura SubstituteAcera Surgical, Inc.K163456DuraGen Secure Dural Regeneration MatrixIntegra LifeSciences Corporation

Official Source

View on FDA Database →

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

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