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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intracardiac Mapping, High-Density Array
510(k) Number K193237
Device Name Carto Octaray Mapping Catheter with Trueref Technology
Applicant
Biosense Webster, Inc.
33 Technology Dr.
Irvin,  CA  92618
Applicant Contact Richard Lauhead
Correspondent
Biosense Webster, Inc.
33 Technology Dr.
Irvin,  CA  92618
Correspondent Contact Richard Lauhead
Regulation Number870.1220
Classification Product Code
MTD  
Date Received11/25/2019
Decision Date 07/31/2020
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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