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Acutus Medical, Inc.

24 FDA 510(k) clearances · Manufacturer

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

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Every clearance here is in the API, with alerts when new ones post.