Syntheon LAA Exclusion System, Syntheon LAA Selection Guide

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide is an FDA 510(k)-cleared medical device (K220305) manufactured by Syntheon. 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 October 27, 2022. Regulation: 8.