
Edwards Lifesciences, LLC
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EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM is an FDA 510(k)-cleared medical device (K141206) manufactured by Edwards Lifesciences, LLC. 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 January 15, 2015. Regulation: 8.