XenoSure Biologic Patch
FDA 510(k) K190882 · Lemaitre Vascular
510(k) numberK190882
Submission
- Device name
- XenoSure Biologic Patch
- Applicant
- Lemaitre Vascular
Burlington, MA, US - Received
- April 4, 2019
- Decision date
- February 13, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PSQ – Intracardiac Patch Or Pledget, Biologically Derived
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3470
- Specialty
- Cardiovascular
- Implant
- Yes
To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.
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| K210331 | CardiaMend Pericardial and Epicardial Reconstruction MatrixPSQ · Traditional | Helios Cardio, Inc. | 12/21/2021SE |
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| K191734 | MatriStem UBM Pericardial PatchPSQ · Traditional | Acell, Inc. | 11/22/2019SE |
| K183635 | PhotoFix Decellularized Bovine PericardiumPSQ · Special | Cryolife, Inc. | 02/14/2019SE |
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| K172085 | PhotoFix Decellularized Bovine PericardiumPSQ · Traditional | Cryolife, Inc. | 12/04/2017SE |
| K172660 | Duravess bovine pericardial vascular patchPSQ · Traditional | Edwards Lifesciences, LLC | 11/17/2017SE |
| K170951 | CardioCel 3DPSQ · Special | Admedus Regen Pty, Ltd. | 04/28/2017SE |
More from Admedus Regen Pty, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K212894 | PhasTIPPDWQ · Traditional | 03/31/2022SE |
| K190267 | EZE SIT ValvulotomeMGZ · Traditional | 10/30/2019SE |
| K183513 | XenoSure Dura Biologic PatchGXQ · Traditional | 06/13/2019SE |
| 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 Biologic Patch cleared by the FDA?
XenoSure Biologic Patch (K190882) received a 510(k) decision of Substantially Equivalent on February 13, 2020, 315 days after the submission was received.
What is the product code of K190882?
The FDA product code is PSQ – Intracardiac Patch Or Pledget, Biologically Derived, a Class II (moderate risk) device regulated under 21 CFR 870.3470.