BARD(R) ENDOCARDIAL BALLOON ARRAY

BARD(R) ENDOCARDIAL BALLOON ARRAY is an FDA 510(k)-cleared medical device (K911140) manufactured by C.R. Bard, 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 May 6, 1991. Regulation: 8.