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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 K210766
Device Name AcQMap 3D Imaging and Mapping Catheter, Model 900009
Applicant
Acutus Medical, Inc.
2210 Faraday Ave, Suite 100
Carlsbad,  CA  92008
Applicant Contact Karla Schaffner
Correspondent
Acutus Medical, Inc.
2210 Faraday Ave, Suite 100
Carlsbad,  CA  92008
Correspondent Contact Karla Schaffner
Regulation Number870.1220
Classification Product Code
MTD  
Subsequent Product Code
ITX  
Date Received03/15/2021
Decision Date 06/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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