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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 K212593
Device Name ViaCath, AcQRate Dx Steerable Catheter
Applicant
Biotronick, Inc.
6024 Jean Rd.
Lake Oswego,  OR  97035
Applicant Contact Jon Brumbaugh
Correspondent
Biotronick, Inc.
6024 Jean Rd.
Lake Oswego,  OR  97035
Correspondent Contact Jon Brumbaugh
Regulation Number870.1220
Classification Product Code
DRF  
Date Received08/16/2021
Decision Date 10/15/2021
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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