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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 K211100
Device Name AcQGuide MAX Steerable Sheath
Applicant
Acutus Medical, Inc.
2210 Faraday Ave., Suite 100
Carlsbad,  CA  92008
Applicant Contact Serena Sanginthirath
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.1280
Classification Product Code
DRA  
Date Received04/13/2021
Decision Date 05/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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