Acutus Medical Inc
FDA Regulatory Profile
Acutus Medical Inc appears in FDA public data with 4 recalls, 24 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1769-2020, Class II) was initiated on February 25, 2020. Its most recent 510(k) clearance was granted on December 17, 2023.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 24
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1769-2020 | Class II | Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal N | February 25, 2020 |
| Z-1768-2020 | Class II | Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112 | February 25, 2020 |
| Z-1771-2020 | Class II | Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Ne | February 25, 2020 |
| Z-1770-2020 | Class II | Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 1 | February 25, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233691 | FlexCath Cross Transseptal Solution | December 17, 2023 |
| K231091 | AcQMap High Resolution Imaging and Mapping System | July 10, 2023 |
| K230606 | AcQMap® High Resolution Imaging and Mapping System | May 2, 2023 |
| K222209 | AcQMap High Resolution Imaging and Mapping System | October 17, 2022 |
| K220784 | AcQMap High Resolution Imaging and Mapping System | July 1, 2022 |
| K210766 | AcQMap 3D Imaging and Mapping Catheter, Model 900009 | June 21, 2022 |
| K221044 | AcQGuide® VUE Steerable Sheath | May 5, 2022 |
| K220047 | AcQCross Qx Integrated Transseptal Dilator/Needle | February 8, 2022 |
| K212345 | AcQMap High Resolution Imaging and Mapping System | August 27, 2021 |
| K210680 | AcQMap High Resolution Imaging and Mapping System | August 5, 2021 |
| K211100 | AcQGuide MAX Steerable Sheath | May 14, 2021 |
| K210685 | AcQCross Qx Integrated Transseptal Dilator/Needle | April 6, 2021 |
| K201015 | AcQMap High Resolution Imaging and Mapping System | December 1, 2020 |
| K201341 | AcQMap 3D Imaging and Mapping Catheter | September 15, 2020 |
| K193013 | AcQMap High Resolution Imaging and Mapping System | February 11, 2020 |
| K193509 | AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX | January 17, 2020 |
| K191392 | AcQMap High Resolution Imaging and Mapping System | September 6, 2019 |
| K192106 | AcQRef Introducer Sheath | September 3, 2019 |
| K190131 | AcQMap High Resolution Imaging and Mapping System | April 2, 2019 |
| K181577 | AcQMap High Resolution Imaging and Mapping System | February 7, 2019 |