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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 K252972
Device Name CARTO™ 3 EP Navigation System V8.4
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 Dorit Eizenberg
Regulation Number870.1425
Classification Product Code
DQK  
Date Received09/17/2025
Decision Date 02/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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