MEDRAD Mark 7 Arterion Injection System

MEDRAD Mark 7 Arterion Injection System is an FDA 510(k)-cleared medical device (K193028) manufactured by Bayer Medical Care, 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 December 4, 2019. Regulation: 8.