FDA 510(k) Applications Submitted by Acutus Medical, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K170819 03/20/2017 AcQMap 3D Imaging and Mapping Catheter Acutus Medical, Inc.
K170948 03/30/2017 AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc.
K171557 05/30/2017 AcQRef Introducer Sheath Acutus Medical, Inc.
K162925 10/19/2016 AcQGuide Steerable Sheath ACUTUS MEDICAL, INC.
K181577 06/15/2018 AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc.
K193509 12/18/2019 AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX Acutus Medical, Inc.
K210766 03/15/2021 AcQMap 3D Imaging and Mapping Catheter, Model 900009 Acutus Medical, Inc.
K201341 05/20/2020 AcQMap 3D Imaging and Mapping Catheter Acutus Medical, Inc.
K191392 05/24/2019 AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc.
K193013 10/29/2019 AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc.
K220047 01/05/2022 AcQCross Qx Integrated Transseptal Dilator/Needle Acutus Medical, Inc.
K221044 04/08/2022 AcQGuide« VUE Steerable Sheath Acutus Medical, Inc.
K233691 11/16/2023 FlexCath Cross Transseptal Solution Acutus Medical, Inc.
K190131 01/28/2019 AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc.
K211100 04/13/2021 AcQGuide MAX Steerable Sheath Acutus Medical, Inc.
K201015 04/17/2020 AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc.
K192106 08/05/2019 AcQRef Introducer Sheath Acutus Medical, Inc.
K210680 03/08/2021 AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc.
K220784 03/17/2022 AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc.
K212345 07/28/2021 AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc.
K230606 03/03/2023 AcQMap« High Resolution Imaging and Mapping System Acutus Medical, Inc.


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