CORONARY SINUS ACCESS KIT, MODEL KCS8F-01

CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 is an FDA 510(k)-cleared medical device (K050808) manufactured by Cardio-Optics, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 27, 2005. Regulation: 8.