510(k) K201341 ยท MTD Catheter, Intracardiac Mapping, High-Density Array
AcQMap 3D Imaging and Mapping Catheter
| Applicant | Acutus Medical, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Sep 15, 2020 |
| Received | May 20, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201341
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.