Carlsbad, CA, US · 16 510(k) clearances · 4 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | Class II | Cardiovascular | 8 | 2023-07-10 |
| DYB | Introducer, Catheter | Class II | Cardiovascular | 4 | 2023-12-17 |
| MTD | Catheter, Intracardiac Mapping, High-Density Array | Class II | Cardiovascular | 2 | 2022-06-21 |
| DRA | Catheter, Steerable | Class II | Cardiovascular | 2 | 2022-05-05 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2020-02-25 | Class II | Terminated | Z-1771-2020 | Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, S… | — | 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 … |
| 2020-02-25 | Class II | Terminated | Z-1770-2020 | Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, R… | — | 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 … |
| 2020-02-25 | Class II | Terminated | Z-1769-2020 | Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 S… | — | 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 … |
| 2020-02-25 | Class II | Terminated | Z-1768-2020 | Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxO… | — | 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 … |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-12-17 | K233691 | FlexCath Cross Transseptal Solution | DYB | Class II | Cardiovascular |
| 2023-07-10 | K231091 | AcQMap High Resolution Imaging and Mapping System | DQK | Class II | Cardiovascular |
| 2023-05-02 | K230606 | AcQMap® High Resolution Imaging and Mapping System | DQK | Class II | Cardiovascular |
| 2022-10-17 | K222209 | AcQMap High Resolution Imaging and Mapping System | DQK | Class II | Cardiovascular |
| 2022-07-01 | K220784 | AcQMap High Resolution Imaging and Mapping System | DQK | Class II | Cardiovascular |
| 2022-06-21 | K210766 | AcQMap 3D Imaging and Mapping Catheter, Model 900009 | MTD | Class II | Cardiovascular |
| 2022-05-05 | K221044 | AcQGuide® VUE Steerable Sheath | DRA | Class II | Cardiovascular |
| 2022-02-08 | K220047 | AcQCross Qx Integrated Transseptal Dilator/Needle | DYB | Class II | Cardiovascular |
| 2021-08-27 | K212345 | AcQMap High Resolution Imaging and Mapping System | DQK | Class II | Cardiovascular |
| 2021-08-05 | K210680 | AcQMap High Resolution Imaging and Mapping System | DQK | Class II | Cardiovascular |
| 2021-05-14 | K211100 | AcQGuide MAX Steerable Sheath | DRA | Class II | Cardiovascular |
| 2021-04-06 | K210685 | AcQCross Qx Integrated Transseptal Dilator/Needle | DYB | Class II | Cardiovascular |
| 2020-12-01 | K201015 | AcQMap High Resolution Imaging and Mapping System | DQK | Class II | Cardiovascular |
| 2020-09-15 | K201341 | AcQMap 3D Imaging and Mapping Catheter | MTD | Class II | Cardiovascular |
| 2020-02-11 | K193013 | AcQMap High Resolution Imaging and Mapping System | DQK | Class II | Cardiovascular |
| 2020-01-17 | K193509 | AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX | DYB | Class II | Cardiovascular |