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Acutus Medical, Inc.

FDA 510(k) & PMA Approved Devices — 24 products

Total Devices24
Categories4
Latest FDA decision2023-12-17
TypeNumberDevice NameCodeDateActions
510(k) K233691 FlexCath Cross Transseptal SolutionDYB2023-12-17 View
510(k) K231091 AcQMap High Resolution Imaging and Mapping SystemDQK2023-07-10 View
510(k) K230606 AcQMap® High Resolution Imaging and Mapping SystemDQK2023-05-02 View
510(k) K222209 AcQMap High Resolution Imaging and Mapping SystemDQK2022-10-17 View
510(k) K220784 AcQMap High Resolution Imaging and Mapping SystemDQK2022-07-01 View
510(k) K210766 AcQMap 3D Imaging and Mapping Catheter, Model 900009MTD2022-06-21 View
510(k) K221044 AcQGuide® VUE Steerable SheathDRA2022-05-05 View
510(k) K220047 AcQCross Qx Integrated Transseptal Dilator/NeedleDYB2022-02-08 View
510(k) K212345 AcQMap High Resolution Imaging and Mapping SystemDQK2021-08-27 View
510(k) K210680 AcQMap High Resolution Imaging and Mapping SystemDQK2021-08-05 View
510(k) K211100 AcQGuide MAX Steerable SheathDRA2021-05-14 View
510(k) K210685 AcQCross Qx Integrated Transseptal Dilator/NeedleDYB2021-04-06 View
510(k) K201015 AcQMap High Resolution Imaging and Mapping SystemDQK2020-12-01 View
510(k) K201341 AcQMap 3D Imaging and Mapping CatheterMTD2020-09-15 View
510(k) K193013 AcQMap High Resolution Imaging and Mapping SystemDQK2020-02-11 View
510(k) K193509 AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QXDYB2020-01-17 View
510(k) K191392 AcQMap High Resolution Imaging and Mapping SystemDQK2019-09-06 View
510(k) K192106 AcQRef Introducer SheathDYB2019-09-03 View
510(k) K190131 AcQMap High Resolution Imaging and Mapping SystemDQK2019-04-02 View
510(k) K181577 AcQMap High Resolution Imaging and Mapping SystemDQK2019-02-07 View

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