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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 K252164
Device Name NorthStar™ Mapping System
Applicant
Imricor Medical Systems
400 Gateway Blvd.
Burnsville,  MN  55337
Applicant Contact Oksana Alswager
Correspondent
Imricor Medical Systems
400 Gateway Blvd.
Burnsville,  MN  55337
Correspondent Contact Oksana Alswager
Regulation Number870.1425
Classification Product Code
DQK  
Date Received07/10/2025
Decision Date 01/28/2026
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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