Intracardiac Patch Or Pledget, Biologically Derived

FDA product code PSQ · Class II (moderate risk) · 21 CFR 870.3470 · Cardiovascular

To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.

11510(k) clearances
0PMA approvals
2recalls
Implantimplanted device

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K221032Vascu-Guard Vascular Repair PatchPSQ · Traditional Synovis Life Technologies, Inc.10/19/2022SE
K221029PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair PatchPSQ · Traditional Synovis Life Technologies, Inc.10/19/2022SE
K210331CardiaMend Pericardial and Epicardial Reconstruction MatrixPSQ · Traditional Helios Cardio, Inc.12/21/2021SE
K200566ADAPT TissuePSQ · Special Admedus Regen Pty, Ltd.04/03/2020SE
K190882XenoSure Biologic PatchPSQ · Traditional Lemaitre Vascular02/13/2020SE
K191734MatriStem UBM Pericardial PatchPSQ · Traditional Acell, Inc.11/22/2019SE
K183635PhotoFix Decellularized Bovine PericardiumPSQ · Special Cryolife, Inc.02/14/2019SE
K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single…PSQ · Traditional Cormatrix Cardiovascular, Inc.10/10/2018SE
K172085PhotoFix Decellularized Bovine PericardiumPSQ · Traditional Cryolife, Inc.12/04/2017SE
K172660Duravess bovine pericardial vascular patchPSQ · Traditional Edwards Lifesciences, LLC11/17/2017SE
K170951CardioCel 3DPSQ · Special Admedus Regen Pty, Ltd.04/28/2017SE

Recalls

RecallProductFirmInitiated
Z-0666-2024 Class IIVascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS…Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed… Baxter Healthcare Corporation12/06/2023Open, Classified
Z-0664-2024 Class IIPeri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) PG1225: 12 X 25…Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed… Baxter Healthcare Corporation12/06/2023Open, Classified