CardiaMend Pericardial and Epicardial Reconstruction Matrix

CardiaMend Pericardial and Epicardial Reconstruction Matrix is an FDA 510(k)-cleared medical device (K210331) manufactured by Helios Cardio, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 20, 2021. Regulation: 8.