FDA 510(k)

XenoSure Biologic Patch

K-Number: K190882 · 2020-02-13

Decision Date2020-02-13

Product CodePSQ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

XenoSure Biologic Patch is a medical device manufactured by Lemaitre Vascular. It received FDA 510(k) clearance on 2020-02-13 under approval number K190882. The device is classified under product code PSQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XenoSure Biologic Patch?

XenoSure Biologic Patch is a medical device that received FDA 510(k) clearance on 2020-02-13. It is manufactured by Lemaitre Vascular. The 510(k) number is K190882.

When was XenoSure Biologic Patch approved by the FDA?

XenoSure Biologic Patch received FDA 510(k) clearance on 2020-02-13, under approval number K190882.

What company makes XenoSure Biologic Patch?

XenoSure Biologic Patch is manufactured by Lemaitre Vascular.

What is the FDA product code for XenoSure Biologic Patch?

The FDA product code for XenoSure Biologic Patch is PSQ.

Other Devices by Lemaitre Vascular

K182916Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr K190267EZE SIT Valvulotome

Related Devices (Code: PSQ)

K172085PhotoFix Decellularized Bovine PericardiumCryolife, Inc. K172660Duravess bovine pericardial vascular patchEdwards Lifesciences, LLC K170951CardioCel 3DAdmedus Regen Pty, Ltd. K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)Cormatrix Cardiovascular, Inc. K191734MatriStem UBM Pericardial PatchAcell, Inc. K183635PhotoFix Decellularized Bovine PericardiumCryolife, Inc.

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.