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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Steerable
510(k) Number K162925
Device Name AcQGuide Steerable 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 Number870.1280
Classification Product Code
DRA  
Date Received10/19/2016
Decision Date 04/06/2017
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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