CVD BULLETT HI-FLO INFUSION CATHETER

CVD BULLETT HI-FLO INFUSION CATHETER is an FDA 510(k)-cleared medical device (K951503) manufactured by Cardiovascular Dynamics, 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 May 3, 1995. Regulation: 8.