RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26

RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26 is an FDA 510(k)-cleared medical device (K093877) 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 June 30, 2010. Regulation: 8.