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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 K191660
Device Name CARTO 3 EP Navigation System, Version 7.1 and Accessories
Applicant
Biosense Webster, Inc.
33 Technology Drive
Irvine,  CA  92618
Applicant Contact Phuong Chau
Correspondent
Biosense Webster, Inc.
33 Technology Drive
Irvine,  CA  92618
Correspondent Contact Phuong Chau
Regulation Number870.1425
Classification Product Code
DQK  
Date Received06/21/2019
Decision Date 07/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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