Acutus Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: FlexCath Cross Transseptal Solution, AcQMap High Resolution Imaging and Mapping System, AcQMap® High Resolution Imaging and Mapping System
24
Total
24
Cleared
0
Denied
FDA 510(k) Regulatory Record - Acutus Medical, Inc. Cardiovascular ✕
24 devices
Cleared
Dec 17, 2023
FlexCath Cross Transseptal Solution
Cardiovascular
31d
Cleared
Jul 10, 2023
AcQMap High Resolution Imaging and Mapping System
Cardiovascular
84d
Cleared
May 02, 2023
AcQMap® High Resolution Imaging and Mapping System
Cardiovascular
60d
Cleared
Oct 17, 2022
AcQMap High Resolution Imaging and Mapping System
Cardiovascular
84d
Cleared
Jul 01, 2022
AcQMap High Resolution Imaging and Mapping System
Cardiovascular
106d
Cleared
Jun 21, 2022
AcQMap 3D Imaging and Mapping Catheter, Model 900009
Cardiovascular
463d
Cleared
May 05, 2022
AcQGuide® VUE Steerable Sheath
Cardiovascular
27d
Cleared
Feb 08, 2022
AcQCross Qx Integrated Transseptal Dilator/Needle
Cardiovascular
34d
Cleared
Aug 27, 2021
AcQMap High Resolution Imaging and Mapping System
Cardiovascular
30d
Cleared
Aug 05, 2021
AcQMap High Resolution Imaging and Mapping System
Cardiovascular
150d
Cleared
May 14, 2021
AcQGuide MAX Steerable Sheath
Cardiovascular
31d
Cleared
Apr 06, 2021
AcQCross Qx Integrated Transseptal Dilator/Needle
Cardiovascular
29d