REFLEXION SPIRAL VARIABLE RADIUS CATHETER

REFLEXION SPIRAL VARIABLE RADIUS CATHETER is an FDA 510(k)-cleared medical device (K072012) manufactured by St Jude Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 21, 2007. Regulation: 8.