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Boston Scientific Scimed, Inc.
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BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020 is an FDA 510(k)-cleared medical device (K000743) manufactured by Boston Scientific Scimed, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 5, 2000. Regulation: 8.