BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER

BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER is an FDA 510(k)-cleared medical device (K993292) 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 22, 2000. Regulation: 8.