CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT

CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT is an FDA 510(k)-cleared medical device (K103215) manufactured by Cianna Medical. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 14, 2010. Regulation: 8.