510(k) K212593 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
ViaCath, AcQRate Dx Steerable Catheter
| Applicant | Biotronick, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Oct 15, 2021 |
| Received | Aug 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212593
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.