Company · US
Acutus Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2023. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 17, 2023 | K233691 | FlexCath Cross Transseptal Solution Acutus Medical, Inc. | DYB |
| Jul 10, 2023 | K231091 | AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc. | DQK |
| May 2, 2023 | K230606 | AcQMap® High Resolution Imaging and Mapping System Acutus Medical, Inc. | DQK |
| Oct 17, 2022 | K222209 | AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc. | DQK |
| Jul 1, 2022 | K220784 | AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc. | DQK |
| Jun 21, 2022 | K210766 | AcQMap 3D Imaging and Mapping Catheter, Model 900009 Acutus Medical, Inc. | MTD |
| May 5, 2022 | K221044 | AcQGuide® VUE Steerable Sheath Acutus Medical, Inc. | DRA |
| Feb 8, 2022 | K220047 | AcQCross Qx Integrated Transseptal Dilator/Needle Acutus Medical, Inc. | DYB |
| Aug 27, 2021 | K212345 | AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc. | DQK |
| Aug 5, 2021 | K210680 | AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc. | DQK |
| May 14, 2021 | K211100 | AcQGuide MAX Steerable Sheath Acutus Medical, Inc. | DRA |
| Apr 6, 2021 | K210685 | AcQCross Qx Integrated Transseptal Dilator/Needle Acutus Medical, Inc. | DYB |
| Dec 1, 2020 | K201015 | AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc. | DQK |
| Sep 15, 2020 | K201341 | AcQMap 3D Imaging and Mapping Catheter Acutus Medical, Inc. | MTD |
| Feb 11, 2020 | K193013 | AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc. | DQK |
| Jan 17, 2020 | K193509 | AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX Acutus Medical, Inc. | DYB |
| Sep 6, 2019 | K191392 | AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc. | DQK |
| Sep 3, 2019 | K192106 | AcQRef Introducer Sheath Acutus Medical, Inc. | DYB |
| Apr 2, 2019 | K190131 | AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc. | DQK |
| Feb 7, 2019 | K181577 | AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc. | DQK |
| Feb 6, 2018 | K171557 | AcQRef Introducer Sheath Acutus Medical, Inc. | DYB |
| Oct 16, 2017 | K170948 | AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc. | DQK |
| Oct 16, 2017 | K170819 | AcQMap 3D Imaging and Mapping Catheter Acutus Medical, Inc. | MTD |
| Apr 6, 2017 | K162925 | AcQGuide Steerable Sheath Acutus Medical, Inc. | DRA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2020 | Acutus Medical Inc Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly Terminated |
DYB | K170373 |
| Apr 23, 2020 | Acutus Medical Inc Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly Terminated |
DYB | K170373 |
| Apr 23, 2020 | Acutus Medical Inc Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly Terminated |
DYB | K170373 |
| Apr 23, 2020 | Acutus Medical Inc Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly Terminated |
DYB | K170373 |