THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH.

THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH. is an FDA 510(k)-cleared medical device (K896597) manufactured by Boston Scientific Corp. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 11, 1990. Regulation: 8.