Medical Device Manufacturer · US , Carlsbad , CA

Acutus Medical, Inc.

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

Acutus Medical, Inc. — FDA 510(k) Submissions

Acutus Medical, Inc. has submitted 24 FDA 510(k) premarket notifications since 2017, of which 24 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Computer, Diagnostic, Programmable, Introducer, Catheter, Catheter, Steerable, Catheter, Intracardiac Mapping, High-density Array . Use the specialty filter in the sidebar to narrow results.

24 devices
1–24 of 24
FlexCath Cross Transseptal Solution
K233691 · DYB Introducer, Catheter · Cardiovascular
Dec 2023 31d
AcQMap High Resolution Imaging and Mapping System
K231091 · DQK Computer, Diagnostic,... · Cardiovascular
Jul 2023 84d
AcQMap? High Resolution Imaging and Mapping System
K230606 · DQK Computer, Diagnostic,... · Cardiovascular
May 2023 60d
AcQMap High Resolution Imaging and Mapping System
K222209 · DQK Computer, Diagnostic,... · Cardiovascular
Oct 2022 84d
AcQMap High Resolution Imaging and Mapping System
K220784 · DQK Computer, Diagnostic,... · Cardiovascular
Jul 2022 106d
AcQMap 3D Imaging and Mapping Catheter, Model 900009
K210766 · MTD Catheter, Intracardiac... · Cardiovascular
Jun 2022 463d
AcQGuide? VUE Steerable Sheath
K221044 · DRA Catheter, Steerable · Cardiovascular
May 2022 27d
AcQCross Qx Integrated Transseptal Dilator/Needle
K220047 · DYB Introducer, Catheter · Cardiovascular
Feb 2022 34d
AcQMap High Resolution Imaging and Mapping System
K212345 · DQK Computer, Diagnostic,... · Cardiovascular
Aug 2021 30d
AcQMap High Resolution Imaging and Mapping System
K210680 · DQK Computer, Diagnostic,... · Cardiovascular
Aug 2021 150d
AcQGuide MAX Steerable Sheath
K211100 · DRA Catheter, Steerable · Cardiovascular
May 2021 31d
AcQCross Qx Integrated Transseptal Dilator/Needle
K210685 · DYB Introducer, Catheter · Cardiovascular
Apr 2021 29d
AcQMap High Resolution Imaging and Mapping System
K201015 · DQK Computer, Diagnostic,... · Cardiovascular
Dec 2020 228d
AcQMap 3D Imaging and Mapping Catheter
K201341 · MTD Catheter, Intracardiac... · Cardiovascular
Sep 2020 118d
AcQMap High Resolution Imaging and Mapping System
K193013 · DQK Computer, Diagnostic,... · Cardiovascular
Feb 2020 105d
AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX
K193509 · DYB Introducer, Catheter · Cardiovascular
Jan 2020 30d
AcQMap High Resolution Imaging and Mapping System
K191392 · DQK Computer, Diagnostic,... · Cardiovascular
Sep 2019 105d
AcQRef Introducer Sheath
K192106 · DYB Introducer, Catheter · Cardiovascular
Sep 2019 29d
AcQMap High Resolution Imaging and Mapping System
K190131 · DQK Computer, Diagnostic,... · Cardiovascular
Apr 2019 64d
AcQMap High Resolution Imaging and Mapping System
K181577 · DQK Computer, Diagnostic,... · Cardiovascular
Feb 2019 237d
AcQRef Introducer Sheath
K171557 · DYB Introducer, Catheter · Cardiovascular
Feb 2018 252d
AcQMap 3D Imaging and Mapping Catheter
K170819 · MTD Catheter, Intracardiac... · Cardiovascular
Oct 2017 210d
AcQMap High Resolution Imaging and Mapping System
K170948 · DQK Computer, Diagnostic,... · Cardiovascular
Oct 2017 200d
AcQGuide Steerable Sheath
K162925 · DRA Catheter, Steerable · Cardiovascular
Apr 2017 169d
Filters
All24 Cardiovascular 24