
Edwards Lifesciences, LLC
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EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M is an FDA 510(k)-cleared medical device (K100709) manufactured by Edwards Lifesciences, 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 6, 2010. Regulation: 8.