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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 K132782
Device Name CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2
Applicant
Biosense Webster, Inc.
3333 Diamond Canyon Rd.
Diamond Bar,  CA  91765
Applicant Contact WAYNE R HOHMAN
Correspondent
Biosense Webster, Inc.
3333 Diamond Canyon Rd.
Diamond Bar,  CA  91765
Correspondent Contact WAYNE R HOHMAN
Regulation Number870.1425
Classification Product Code
DQK  
Date Received09/06/2013
Decision Date 01/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01385202
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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