ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS

ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS is an FDA 510(k)-cleared medical device (K093965) manufactured by C.R. Bard, 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 March 16, 2010. Regulation: 8.