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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 K171557
Device Name AcQRef Introducer Sheath
Applicant
Acutus Medical, Inc.
2210 Faraday Ave., Suite 100
Carlsbad,  CA  92008
Applicant Contact Brenda Clay
Correspondent
Acutus Medical, Inc.
2210 Faraday Ave., Suite 100
Carlsbad,  CA  92008
Correspondent Contact Brenda Clay
Regulation Number870.1340
Classification Product Code
DYB  
Date Received05/30/2017
Decision Date 02/06/2018
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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