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Boston Scientific Corp
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MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX is an FDA 510(k)-cleared medical device (K052783) 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 October 26, 2005. Regulation: 8.