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Edwards Lifesciences, LLC
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EDWARDS PERCUTANEOUS SHEATH INTRODUCER is an FDA 510(k)-cleared medical device (K121185) 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 August 21, 2012. Regulation: 8.