PreSep Oligon Oximetry Catheter

PreSep Oligon Oximetry Catheter is an FDA 510(k)-cleared medical device (K160645) 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 15, 2016. Regulation: 8.