Name: Predicase
Price: 199 USD

K-number	K230453
Device name	OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter
Applicant	Boston Scientific Corporation
Product code	OBJ
Device class	Class II
Decision date	May 18, 2023
Decision	Substantially Equivalent
Regulation	870.1200

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Source

View the full FDA submission: accessdata.fda.gov

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OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter

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