Panels › Cardiovascular › Product code PSQ · Class 2
Intracardiac Patch Or Pledget, Biologically Derived
Regulation 870.3470
0510(k)s in 12 months (11 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in PSQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Admedus Regen Pty, Ltd. | 2 | 0 |
| Baxter Healthcare Corporation | 0 | 2 |
| Cryolife, Inc. | 2 | 0 |
| Synovis Life Technologies, Inc. | 2 | 0 |
| Acell, Inc. | 1 | 0 |
| Cormatrix Cardiovascular, Inc. | 1 | 0 |
| Edwards Lifesciences, LLC | 1 | 0 |
| Helios Cardio, Inc. | 1 | 0 |
| Lemaitre Vascular | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 19, 2022 | K221032 | Vascu-Guard Vascular Repair Patch Synovis Life Technologies, Inc. | PSQ |
| Oct 19, 2022 | K221029 | PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch Synovis Life Technologies, Inc. | PSQ |
| Dec 21, 2021 | K210331 | CardiaMend Pericardial and Epicardial Reconstruction Matrix Helios Cardio, Inc. | PSQ |
| Apr 3, 2020 | K200566 | ADAPT Tissue Admedus Regen Pty, Ltd., AU | PSQ |
| Feb 13, 2020 | K190882 | XenoSure Biologic Patch Lemaitre Vascular | PSQ |
| Nov 22, 2019 | K191734 | MatriStem UBM Pericardial Patch Acell, Inc. | PSQ |
| Feb 14, 2019 | K183635 | PhotoFix Decellularized Bovine Pericardium Cryolife, Inc. | PSQ |
| Oct 10, 2018 | K181038 | CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 c Cormatrix Cardiovascular, Inc. | PSQ |
| Dec 4, 2017 | K172085 | PhotoFix Decellularized Bovine Pericardium Cryolife, Inc. | PSQ |
| Nov 17, 2017 | K172660 | Duravess bovine pericardial vascular patch Edwards Lifesciences, LLC | PSQ |
| Apr 28, 2017 | K170951 | CardioCel 3D Admedus Regen Pty, Ltd., AU | PSQ |
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