
Datascope Corp., Cardiac Assist Division
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AIR-BAND RADIAL COMPRESSION DEVICE is an FDA 510(k)-cleared medical device (K122405) manufactured by Datascope Corp., Cardiac Assist Division. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 8, 2012. Regulation: 8.