ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS

ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS is an FDA 510(k)-cleared medical device (K895433) manufactured by Aries 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 April 9, 1990. Regulation: 8.