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Acutus Medical, Inc.

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

Total Devices24
Categories4
Latest Approval2023-12-17
TypeNumberDevice NameCodeDate
510(k) K233691 FlexCath Cross Transseptal Solution DYB 2023-12-17 View
510(k) K231091 AcQMap High Resolution Imaging and Mapping System DQK 2023-07-10 View
510(k) K230606 AcQMap® High Resolution Imaging and Mapping System DQK 2023-05-02 View
510(k) K222209 AcQMap High Resolution Imaging and Mapping System DQK 2022-10-17 View
510(k) K220784 AcQMap High Resolution Imaging and Mapping System DQK 2022-07-01 View
510(k) K210766 AcQMap 3D Imaging and Mapping Catheter, Model 900009 MTD 2022-06-21 View
510(k) K221044 AcQGuide® VUE Steerable Sheath DRA 2022-05-05 View
510(k) K220047 AcQCross Qx Integrated Transseptal Dilator/Needle DYB 2022-02-08 View
510(k) K212345 AcQMap High Resolution Imaging and Mapping System DQK 2021-08-27 View
510(k) K210680 AcQMap High Resolution Imaging and Mapping System DQK 2021-08-05 View
510(k) K211100 AcQGuide MAX Steerable Sheath DRA 2021-05-14 View
510(k) K210685 AcQCross Qx Integrated Transseptal Dilator/Needle DYB 2021-04-06 View
510(k) K201015 AcQMap High Resolution Imaging and Mapping System DQK 2020-12-01 View
510(k) K201341 AcQMap 3D Imaging and Mapping Catheter MTD 2020-09-15 View
510(k) K193013 AcQMap High Resolution Imaging and Mapping System DQK 2020-02-11 View
510(k) K193509 AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX DYB 2020-01-17 View
510(k) K191392 AcQMap High Resolution Imaging and Mapping System DQK 2019-09-06 View
510(k) K192106 AcQRef Introducer Sheath DYB 2019-09-03 View
510(k) K190131 AcQMap High Resolution Imaging and Mapping System DQK 2019-04-02 View
510(k) K181577 AcQMap High Resolution Imaging and Mapping System DQK 2019-02-07 View
510(k) K171557 AcQRef Introducer Sheath DYB 2018-02-06 View
510(k) K170948 AcQMap High Resolution Imaging and Mapping System DQK 2017-10-16 View
510(k) K170819 AcQMap 3D Imaging and Mapping Catheter MTD 2017-10-16 View
510(k) K162925 AcQGuide Steerable Sheath DRA 2017-04-06 View
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