MitraPatch Mitral Valve Repair System

MitraPatch Mitral Valve Repair System is an FDA 510(k)-cleared medical device (K252126) manufactured by Chawla Heart Technologies, LLC. 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 3, 2025. Regulation: 8.