K-number	K161125
Device name	OptiCross X, 40 MHz Coronary Imaging Catheter
Applicant	Boston Scientific Corporation
Product code	OBJ
Device class	Class II
Decision date	May 19, 2016
Decision	Substantially Equivalent
Regulation	870.1200

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Source

View the full FDA submission: accessdata.fda.gov

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OptiCross X, 40 MHz Coronary Imaging Catheter

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