RMI EXTERNAL CORONARY ARTERY OCCLUDER

RMI EXTERNAL CORONARY ARTERY OCCLUDER is an FDA 510(k)-cleared medical device (K920936) manufactured by Research 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 December 17, 1992. Regulation: 8.