Name: Predicase
Price: 199 USD

K-number	K173977
Device name	CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module
Applicant	Biosense Webster, Inc.
Product code	DQK
Device class	Class II
Decision date	Jun 14, 2018
Decision	Substantially Equivalent
Regulation	870.1425

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Source

View the full FDA submission: accessdata.fda.gov

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CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module

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