Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Acutus Medical with 24 510(k) clearances and 4 device recalls. The most recent is a 510(k) clearance dated Dec 17, 2023: FlexCath Cross Transseptal Solution.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 17, 2023 | FlexCath Cross Transseptal SolutionK233691 · DYB | 510(k) clearances |
| Jul 10, 2023 | AcQMap High Resolution Imaging and Mapping SystemK231091 · DQK | 510(k) clearances |
| May 2, 2023 | AcQMap® High Resolution Imaging and Mapping SystemK230606 · DQK | 510(k) clearances |
| Oct 17, 2022 | AcQMap High Resolution Imaging and Mapping SystemK222209 · DQK | 510(k) clearances |
| Jul 1, 2022 | AcQMap High Resolution Imaging and Mapping SystemK220784 · DQK | 510(k) clearances |
| Jun 21, 2022 | AcQMap 3D Imaging and Mapping Catheter, Model 900009K210766 · MTD | 510(k) clearances |
| May 5, 2022 | AcQGuide® VUE Steerable SheathK221044 · DRA | 510(k) clearances |
| Feb 8, 2022 | AcQCross Qx Integrated Transseptal Dilator/NeedleK220047 · DYB | 510(k) clearances |
| Feb 25, 2020 | Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnlyClass II · It has been determined that the manufacturing process may have left foreign material particulates on the finished device | Device recalls |
| Feb 25, 2020 | Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnlyClass II · It has been determined that the manufacturing process may have left foreign material particulates on the finished device | Device recalls |
| Feb 25, 2020 | Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnlyClass II · It has been determined that the manufacturing process may have left foreign material particulates on the finished device | Device recalls |
| Feb 25, 2020 | Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnlyClass II · It has been determined that the manufacturing process may have left foreign material particulates on the finished device | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
