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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, catheter
510(k) Number K192106
Device Name AcQRef Introducer Sheath
Applicant
Acutus Medical, Inc.
2210 Faraday Ave., Suite 100
Carlsbad,  CA  92008
Applicant Contact Serena Sanginthirath
Correspondent
Acutus Medical, Inc.
2210 Faraday Ave., Suite 100
Carlsbad,  CA  92008
Correspondent Contact Serena Sanginthirath
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/05/2019
Decision Date 09/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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