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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 K231312
Device Name PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID
Applicant
Biosense Webster Inc.
31 Technology Drive, Suite 200
Irvine,  CA  92618
Applicant Contact Caleb Lau
Correspondent
Biosense Webster Inc.
31 Technology Drive, Suite 200
Irvine,  CA  92618
Correspondent Contact Caleb Lau
Regulation Number870.1220
Classification Product Code
MTD  
Subsequent Product Code
DRF  
Date Received05/05/2023
Decision Date 07/10/2023
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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