40CC PERCUTANEOUS FURL SINGLE INTRA-AORTIC BALLOON

40CC PERCUTANEOUS FURL SINGLE INTRA-AORTIC BALLOON is an FDA 510(k)-cleared medical device (K863185) 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 January 15, 1987. Regulation: 8.