DyeVert PLUS EZ Contrast Reduction System

DyeVert PLUS EZ Contrast Reduction System is an FDA 510(k)-cleared medical device (K181936) manufactured by Osprey Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 24, 2018. Regulation: 8.