Acutus Medical, Inc.
Carlsbad, CA, US
Acutus Medical, Inc. appears in FDA device records in Carlsbad, CA. FDA records list 24 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 24 510(k) clearances for Acutus Medical, Inc. between 2017 and 2023. The busiest year on record is 2022, with 5. The most recent is 2023, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 3 |
| 2018 | 1 |
| 2019 | 4 |
| 2020 | 4 |
| 2021 | 4 |
| 2022 | 5 |
| 2023 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233691 | FlexCath Cross Transseptal Solution | DYB | Substantially Equivalent | |
| K231091 | AcQMap High Resolution Imaging and Mapping System | DQK | Substantially Equivalent | |
| K230606 | AcQMap® High Resolution Imaging and Mapping System | DQK | Substantially Equivalent | |
| K222209 | AcQMap High Resolution Imaging and Mapping System | DQK | Substantially Equivalent | |
| K220784 | AcQMap High Resolution Imaging and Mapping System | DQK | Substantially Equivalent | |
| K210766 | AcQMap 3D Imaging and Mapping Catheter, Model 900009 | MTD | Substantially Equivalent | |
| K221044 | AcQGuide® VUE Steerable Sheath | DRA | Substantially Equivalent | |
| K220047 | AcQCross Qx Integrated Transseptal Dilator/Needle | DYB | Substantially Equivalent | |
| K212345 | AcQMap High Resolution Imaging and Mapping System | DQK | Substantially Equivalent | |
| K210680 | AcQMap High Resolution Imaging and Mapping System | DQK | Substantially Equivalent | |
| K211100 | AcQGuide MAX Steerable Sheath | DRA | Substantially Equivalent | |
| K210685 | AcQCross Qx Integrated Transseptal Dilator/Needle | DYB | Substantially Equivalent | |
| K201015 | AcQMap High Resolution Imaging and Mapping System | DQK | Substantially Equivalent | |
| K201341 | AcQMap 3D Imaging and Mapping Catheter | MTD | Substantially Equivalent | |
| K193013 | AcQMap High Resolution Imaging and Mapping System | DQK | Substantially Equivalent | |
| K193509 | AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX | DYB | Substantially Equivalent | |
| K191392 | AcQMap High Resolution Imaging and Mapping System | DQK | Substantially Equivalent | |
| K192106 | AcQRef Introducer Sheath | DYB | Substantially Equivalent | |
| K190131 | AcQMap High Resolution Imaging and Mapping System | DQK | Substantially Equivalent | |
| K181577 | AcQMap High Resolution Imaging and Mapping System | DQK | Substantially Equivalent | |
| K171557 | AcQRef Introducer Sheath | DYB | Substantially Equivalent | |
| K170948 | AcQMap High Resolution Imaging and Mapping System | DQK | Substantially Equivalent | |
| K170819 | AcQMap 3D Imaging and Mapping Catheter | MTD | Substantially Equivalent | |
| K162925 | AcQGuide Steerable Sheath | DRA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1771-2020 | Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly | It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism. | Class II | Terminated | |
| Z-1770-2020 | Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly | It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism. | Class II | Terminated | |
| Z-1769-2020 | Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly | It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism. | Class II | Terminated | |
| Z-1768-2020 | Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly | It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain