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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 K223666
Device Name Ablacath™ Mapping Catheter
Applicant
Ablacon, Inc.
4800 Wadsworth Blvd. Suite 310
Denver,  CO  80033
Applicant Contact Frank Rodriguez
Correspondent
Honkanen Consulting, Inc.
738 Saddle Wood Dr.
Eagan,  MN  55123
Correspondent Contact Laurie Lewandowski
Regulation Number870.1220
Classification Product Code
MTD  
Date Received12/07/2022
Decision Date 03/17/2023
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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