
AtriCure, Inc.
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Isolator Synergy EnCapture Ablation System (EMH) is an FDA 510(k)-cleared medical device (K234151) manufactured by AtriCure, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 26, 2024. Regulation: 8.