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. |
| 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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