510(k) K170819 ยท MTD Catheter, Intracardiac Mapping, High-Density Array
AcQMap 3D Imaging and Mapping Catheter
| Applicant | Acutus Medical, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Oct 16, 2017 |
| Received | Mar 20, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170819
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.