ARROW KINK RESISTANT FLEXI-CATH INTRA-AORTIC BALLOON

ARROW KINK RESISTANT FLEXI-CATH INTRA-AORTIC BALLOON is an FDA 510(k)-cleared medical device (K945230) 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 May 8, 1995. Regulation: 8.