K-number	K213264
Device name	CARTO 3 EP Navigation System Version 7.2
Applicant	Biosense Webster, Inc.
Product code	DQK
Device class	Class II
Decision date	Oct 29, 2021
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 7.2

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