DIVER C.E. CATHETER

DIVER C.E. CATHETER is an FDA 510(k)-cleared medical device (K050276) manufactured by Invatec Innovative Technologies, S.R.L.. 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 6, 2005. Regulation: 8.