K-number	K093455
Device name	CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES
Applicant	Biosense Webster, Inc.
Product code	DQK
Device class	Class II
Decision date	Dec 4, 2009
Decision	Substantially Equivalent
Regulation	870.1425

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View the full FDA submission: accessdata.fda.gov

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CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES

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