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Boston Scientific Corporation
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FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX is an FDA 510(k)-cleared medical device (K111485) manufactured by Boston Scientific Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 29, 2011. Regulation: 8.