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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K252794
Device Name Vision-MR™ Diagnostic Catheter
Applicant
Imricor Medical Systems, Inc.
400 Gateway Blvd.
Burnsville,  MN  55337
Applicant Contact Jordan Todd
Correspondent
Imricor Medical Systems, Inc.
400 Gateway Blvd.
Burnsville,  MN  55337
Correspondent Contact Jordan Todd
Regulation Number870.1220
Classification Product Code
DRF  
Date Received09/02/2025
Decision Date 01/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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