Medical Device Manufacturer · US , Carlsbad , CA

Acutus Medical, Inc. - FDA 510(k) Cleared Devices

24 submissions · 24 cleared · Since 2017
24
Total
24
Cleared
0
Denied

Acutus Medical, Inc. has 24 FDA 510(k) cleared cardiovascular devices. Based in Carlsbad, US.

Last cleared in 2023. Active since 2017.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.

FDA 510(k) Regulatory Record - Acutus Medical, Inc.
24 devices
1-24 of 24
Cleared Dec 17, 2023
FlexCath Cross Transseptal Solution
K233691 · DYB
Cardiovascular · 31d
Cleared Jul 10, 2023
AcQMap High Resolution Imaging and Mapping System
K231091 · DQK
Cardiovascular · 84d
Cleared May 02, 2023
AcQMap® High Resolution Imaging and Mapping System
K230606 · DQK
Cardiovascular · 60d
Cleared Oct 17, 2022
AcQMap High Resolution Imaging and Mapping System
K222209 · DQK
Cardiovascular · 84d
Cleared Jul 01, 2022
AcQMap High Resolution Imaging and Mapping System
K220784 · DQK
Cardiovascular · 106d
Cleared Jun 21, 2022
AcQMap 3D Imaging and Mapping Catheter, Model 900009
K210766 · MTD
Cardiovascular · 463d
Cleared May 05, 2022
AcQGuide® VUE Steerable Sheath
K221044 · DRA
Cardiovascular · 27d
Cleared Feb 08, 2022
AcQCross Qx Integrated Transseptal Dilator/Needle
K220047 · DYB
Cardiovascular · 34d
Cleared Aug 27, 2021
AcQMap High Resolution Imaging and Mapping System
K212345 · DQK
Cardiovascular · 30d
Cleared Aug 05, 2021
AcQMap High Resolution Imaging and Mapping System
K210680 · DQK
Cardiovascular · 150d
Cleared May 14, 2021
AcQGuide MAX Steerable Sheath
K211100 · DRA
Cardiovascular · 31d
Cleared Apr 06, 2021
AcQCross Qx Integrated Transseptal Dilator/Needle
K210685 · DYB
Cardiovascular · 29d
Cleared Dec 01, 2020
AcQMap High Resolution Imaging and Mapping System
K201015 · DQK
Cardiovascular · 228d
Cleared Sep 15, 2020
AcQMap 3D Imaging and Mapping Catheter
K201341 · MTD
Cardiovascular · 118d
Cleared Feb 11, 2020
AcQMap High Resolution Imaging and Mapping System
K193013 · DQK
Cardiovascular · 105d
Cleared Jan 17, 2020
AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX
K193509 · DYB
Cardiovascular · 30d
Cleared Sep 06, 2019
AcQMap High Resolution Imaging and Mapping System
K191392 · DQK
Cardiovascular · 105d
Cleared Sep 03, 2019
AcQRef Introducer Sheath
K192106 · DYB
Cardiovascular · 29d
Cleared Apr 02, 2019
AcQMap High Resolution Imaging and Mapping System
K190131 · DQK
Cardiovascular · 64d
Cleared Feb 07, 2019
AcQMap High Resolution Imaging and Mapping System
K181577 · DQK
Cardiovascular · 237d
Cleared Feb 06, 2018
AcQRef Introducer Sheath
K171557 · DYB
Cardiovascular · 252d
Cleared Oct 16, 2017
AcQMap 3D Imaging and Mapping Catheter
K170819 · MTD
Cardiovascular · 210d
Cleared Oct 16, 2017
AcQMap High Resolution Imaging and Mapping System
K170948 · DQK
Cardiovascular · 200d
Cleared Apr 06, 2017
AcQGuide Steerable Sheath
K162925 · DRA
Cardiovascular · 169d
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