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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 K201750
Device Name Pentaray Nav eco High-Density Mapping Catheter
Applicant
Biosense Webster, Inc
33 Technology Dr
Irvine,  CA  92618
Applicant Contact Richard Lauhead
Correspondent
Biosense Webster, Inc
33 Technology Dr
Irvine,  CA  92618
Correspondent Contact Richard Lauhead
Regulation Number870.1220
Classification Product Code
MTD  
Date Received06/26/2020
Decision Date 08/06/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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