Passeo-18 Peripheral Dilation Catheter

Passeo-18 Peripheral Dilation Catheter is an FDA 510(k)-cleared medical device (K151744) manufactured by Biotronik, 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 October 7, 2015. Regulation: 8.