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 |