FDA 510(k) Applications for Medical Device Product Code: PSQ ()

FDA 510(k) Applications for Medical Device Product Code "PSQ"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K191734	Acell, Inc.	MatriStem UBM Pericardial Patch	11/22/2019
K170951	Admedus Regen Pty Ltd	CardioCel 3D	04/28/2017
K181038	CorMatrix Cardiovascular, Inc.	CorMatrix 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)	10/10/2018
K172085	CryoLife, Inc.	PhotoFix Decellularized Bovine Pericardium	12/04/2017
K183635	CryoLife, Inc.	PhotoFix Decellularized Bovine Pericardium	02/14/2019
K172660	Edwards Lifesciences, LLC	Duravess bovine pericardial vascular patch	11/17/2017
K210331	Helios Cardio Inc.	CardiaMend Pericardial and Epicardial Reconstruction Matrix	12/21/2021
K190882	LeMaitre Vascular	XenoSure Biologic Patch	02/13/2020
K221029	Synovis Life Technologies, Inc.	PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch	10/19/2022
K221032	Synovis Life Technologies, Inc.	Vascu-Guard Vascular Repair Patch	10/19/2022