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Boston Scientific Corp
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ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014 is an FDA 510(k)-cleared medical device (K050577) manufactured by Boston Scientific Corp. 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 29, 2005. Regulation: 8.