Arrow FiberOptix Intra-Aortic Balloon Catheter Kit

Arrow FiberOptix Intra-Aortic Balloon Catheter Kit is an FDA 510(k)-cleared medical device (K200634) manufactured by Arrow International, 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 April 8, 2020. Regulation: 8.