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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 K241372
Device Name Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™
Applicant
Abbott Medical
5050 Nathan Lane N.
Plymouth, Mn,  MN  55442
Applicant Contact Samantha Stretar
Correspondent
Abbott Medical
5050 Nathan Lane N.
Plymouth, Mn,  MN  55442
Correspondent Contact Samantha Stretar
Regulation Number870.1220
Classification Product Code
MTD  
Date Received05/15/2024
Decision Date 07/09/2024
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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