9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM

9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM is an FDA 510(k)-cleared medical device (K963104) 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 3, 1997. Regulation: 8.