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

FDA 510(k) cleared devices by Acutus Medical, Inc. Cardiovascular ✕

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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