Name: Predicase
Price: 199 USD

K-number	K173820
Device name	OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU)
Applicant	Boston Scientific Corporation
Product code	OBJ
Device class	Class II
Decision date	Jan 17, 2018
Decision	Substantially Equivalent
Regulation	870.1200

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Source

View the full FDA submission: accessdata.fda.gov

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OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU)

Everything you need for a 510(k) submission. Nothing you don't.