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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 K252302
Device Name CARTO™ 3 EP Navigation System V8.1
Applicant
Biosense Webster, Inc.
31 Technology Dr., Suite 200
Irvine,  CA  92618
Applicant Contact Caleb Lau
Correspondent
Biosense Webster, Ltd.
4 Hatnufa St.
Yokneam,  IL 2066717
Correspondent Contact Eyal Hendel
Regulation Number870.1425
Classification Product Code
DQK  
Date Received07/24/2025
Decision Date 08/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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