Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

XenoSure Biologic Patch

K-Number: K190882 · 2020-02-13

ApplicantLemaitre Vascular
Decision Date2020-02-13
Product CodePSQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

XenoSure Biologic Patch is the device name listed in this FDA 510(k) record. The listed applicant is Lemaitre Vascular. It received FDA 510(k) clearance on 2020-02-13 under 510(k) 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. The listed applicant is Lemaitre Vascular. The 510(k) number is K190882.

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

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

Who is the listed applicant for XenoSure Biologic Patch?

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

What is the FDA product code for XenoSure Biologic Patch?

The FDA product code for XenoSure Biologic Patch is PSQ.

Other records listing Lemaitre Vascular 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 greaterK212894PhasTIPPK190267EZE SIT ValvulotomeK183513XenoSure Dura Biologic PatchK182916Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 FrPMA P020049Tissue graft of 6mm and greater

View all 9 devices →

Related Devices (Code: PSQ)

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.

K221032Vascu-Guard Vascular Repair PatchSynovis Life Technologies, Inc.K221029PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair PatchSynovis Life Technologies, Inc.K210331CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc.K200566ADAPT TissueAdmedus Regen Pty, Ltd.K191734MatriStem UBM Pericardial PatchAcell, Inc.K183635PhotoFix Decellularized Bovine PericardiumCryolife, Inc.

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.

↑