510(k) K210766 ยท MTD Catheter, Intracardiac Mapping, High-Density Array
AcQMap 3D Imaging and Mapping Catheter, Model 900009
| Applicant | Acutus Medical, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jun 21, 2022 |
| Received | Mar 15, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210766
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.