XenoSure Dura Biologic Patch
FDA 510(k) K183513 · LeMaitre Vascular, Inc.
510(k) numberK183513
Submission
- Device name
- XenoSure Dura Biologic Patch
- Applicant
- LeMaitre Vascular, Inc.
Burlington, MA, US - Received
- December 18, 2018
- Decision date
- June 13, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GXQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251191 | Collagen Dura Regeneration Membrane - RepairGXQ · Traditional | Collagen Matrix, Inc. | 11/18/2025SE |
| K250420 | Helios Dura Regeneration MatrixGXQ · Traditional | Helios Biomedical, Inc. | 05/14/2025SE |
| K223445 | ArtiFasciaGXQ · Traditional | Nurami Medical , Ltd. | 08/10/2023SE |
| K212943 | SyntheCel Dura RepairGXQ · Traditional | Synthes (USA) Products, LLC | 01/28/2022SE |
| K172603 | Cerafix Dura SubstituteGXQ · Traditional | Acera Surgical, Inc. | 11/27/2017SE |
| K163456 | DuraGen Secure Dural Regeneration MatrixGXQ · Special | Integra LifeSciences Corporation | 01/06/2017SE |
| K161370 | Durepair Dura Regeneration MatrixGXQ · Traditional | Medtronic Neurosurgery | 11/02/2016SE |
| K161278 | Cerafix Dura SubstituteGXQ · Traditional | Acera Surgical, Inc. | 08/08/2016SE |
| K153613 | Cerafix Dura SubstituteGXQ · Traditional | Acera Surgical, Inc. | 03/16/2016SE |
| K150825 | Collagen Dural Regeneration MatrixGXQ · Traditional | Collagen Matrix, Inc. | 11/20/2015SE |
More from Collagen Matrix, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K212894 | PhasTIPPDWQ · Traditional | 03/31/2022SE |
| K190882 | XenoSure Biologic PatchPSQ · Traditional | 02/13/2020SE |
| K190267 | EZE SIT ValvulotomeMGZ · Traditional | 10/30/2019SE |
| K182916 | Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt…MJN · Special | 11/16/2018SE |
| K173323 | AnastoClip GC Closure SystemFZP · Traditional | 03/08/2018SE |
| K152833 | Pruitt F3-S Polyurethane Carotid ShuntMJN · Traditional | 01/21/2016SE |
| K143454 | Pruitt F3-S Carotid ShuntMJN · Traditional | 08/27/2015SE |
| K142660 | Antegrade LeMills ValvulotomeMGZ · Special | 10/17/2014SE |
| K140042 | 1.5MM Hydro Expandable Lemaitre ValvulotomeMGZ · Traditional | 04/10/2014SE |
| K133026 | Unballoon Non-Occlusion Modeling CatheterDQY · Traditional | 12/31/2013SE |
Questions and answers
When was XenoSure Dura Biologic Patch cleared by the FDA?
XenoSure Dura Biologic Patch (K183513) received a 510(k) decision of Substantially Equivalent on June 13, 2019, 177 days after the submission was received.
What is the product code of K183513?
The FDA product code is GXQ – Dura Substitute, a Class II (moderate risk) device regulated under 21 CFR 882.5910.