8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER

8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER is an FDA 510(k)-cleared medical device (K993966) 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 February 17, 2000. Regulation: 8.