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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K173977
Device Name CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module
Applicant
Biosense Webster, Inc.
33 Technology Dr.
Irvin,  CA  92618
Applicant Contact Phuong Chau
Correspondent
Biosense Webster, Inc.
33 Technology Dr.
Irvin,  CA  92618
Correspondent Contact Phuong Chau
Regulation Number870.1425
Classification Product Code
DQK  
Date Received12/29/2017
Decision Date 06/14/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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