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Acutus Medical Inc

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
24
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1770-2020Class IIRhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 1February 25, 2020
Z-1768-2020Class IIRhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112February 25, 2020
Z-1771-2020Class IIAcutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal NeFebruary 25, 2020
Z-1769-2020Class IIAcutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal NFebruary 25, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K233691FlexCath Cross Transseptal SolutionDecember 17, 2023
K231091AcQMap High Resolution Imaging and Mapping SystemJuly 10, 2023
K230606AcQMap® High Resolution Imaging and Mapping SystemMay 2, 2023
K222209AcQMap High Resolution Imaging and Mapping SystemOctober 17, 2022
K220784AcQMap High Resolution Imaging and Mapping SystemJuly 1, 2022
K210766AcQMap 3D Imaging and Mapping Catheter, Model 900009June 21, 2022
K221044AcQGuide® VUE Steerable SheathMay 5, 2022
K220047AcQCross Qx Integrated Transseptal Dilator/NeedleFebruary 8, 2022
K212345AcQMap High Resolution Imaging and Mapping SystemAugust 27, 2021
K210680AcQMap High Resolution Imaging and Mapping SystemAugust 5, 2021
K211100AcQGuide MAX Steerable SheathMay 14, 2021
K210685AcQCross Qx Integrated Transseptal Dilator/NeedleApril 6, 2021
K201015AcQMap High Resolution Imaging and Mapping SystemDecember 1, 2020
K201341AcQMap 3D Imaging and Mapping CatheterSeptember 15, 2020
K193013AcQMap High Resolution Imaging and Mapping SystemFebruary 11, 2020
K193509AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QXJanuary 17, 2020
K191392AcQMap High Resolution Imaging and Mapping SystemSeptember 6, 2019
K192106AcQRef Introducer SheathSeptember 3, 2019
K190131AcQMap High Resolution Imaging and Mapping SystemApril 2, 2019
K181577AcQMap High Resolution Imaging and Mapping SystemFebruary 7, 2019