DeRoyal Angiography Kits

DeRoyal Angiography Kits is an FDA 510(k)-cleared medical device (K152978) manufactured by Deroyal Industries, 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 March 24, 2016. Regulation: 8.