ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER

ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER is an FDA 510(k)-cleared medical device (K961358) manufactured by Arrow Intl., 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 July 1, 1996. Regulation: 8.