K-number	DEN140009
Device name	AMIGO REMOTE CATHETER SYSTEM
Applicant	Catheter Robotics, Inc.
Product code	PJB
Device class	Class II
Decision date	Dec 18, 2014
Decision	Not Substantially Equivalent
Regulation	870.5700

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View the full FDA submission: accessdata.fda.gov

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AMIGO REMOTE CATHETER SYSTEM

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