ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975

ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975 is an FDA 510(k)-cleared medical device (K010707) manufactured by Boston Scientific, Target. 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 28, 2001. Regulation: 8.