Cleared Traditional

XenoSure Biologic Patch (K190882) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190882 · Lemaitre Vascular · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
315d
Days
Class 2
Risk

K190882 is an FDA 510(k) clearance for the XenoSure Biologic Patch. Classified as Intracardiac Patch Or Pledget, Biologically Derived (product code PSQ), Class II - Special Controls.

Submitted by Lemaitre Vascular (Burlington, US). The FDA issued a Cleared decision on February 13, 2020 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 870.3470 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Lemaitre Vascular devices

Submission Details

510(k) Number K190882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2019
Decision Date February 13, 2020
Days to Decision 315 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
200d slower than avg
Panel avg: 115d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PSQ Intracardiac Patch Or Pledget, Biologically Derived
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3470
Definition To Repair Defects, To Be Used For Patch Grafting, To Repair Tissue, And To Buttress Sutures In The Heart And Vasculature.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - PSQ Intracardiac Patch Or Pledget, Biologically Derived

All 10
Devices cleared under the same product code (PSQ) and FDA review panel - the closest regulatory comparables to K190882.
PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch
K221029 · Synovis Life Technologies, Inc. · Oct 2022
Vascu-Guard Vascular Repair Patch
K221032 · Synovis Life Technologies, Inc. · Oct 2022
CardiaMend Pericardial and Epicardial Reconstruction Matrix
K210331 · Helios Cardio, Inc. · Dec 2021
ADAPT Tissue
K200566 · Admedus Regen Pty, Ltd. · Apr 2020
MatriStem UBM Pericardial Patch
K191734 · Acell, Inc. · Nov 2019
PhotoFix Decellularized Bovine Pericardium
K183635 · Cryolife, Inc. · Feb 2019