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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 K231207
Device Name CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
Applicant
Biosense Webster, Inc.
31 Technology Drive, Suite 200
Irvine,  CA  92618
Applicant Contact Caleb Lau
Correspondent
Biosense Webster, Inc.
31 Technology Drive, Suite 200
Irvine,  CA  92618
Correspondent Contact Caleb Lau
Regulation Number870.1425
Classification Product Code
DQK  
Date Received04/27/2023
Decision Date 09/07/2023
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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