Name: Predicase
Price: 199 USD

K-number	K180238
Device name	CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT
Applicant	Biosense Webster, Inc.
Product code	DQK
Device class	Class II
Decision date	Jun 1, 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 6.0 and Accessories with VISITAG SURPOINT

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