
AtriCure, Inc.
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AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV) is an FDA 510(k)-cleared medical device (K233407) 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 November 1, 2023. Regulation: 8.