510(k) K201445 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
MultiCath, AcQRate Dx Fixed Curve Catheter
| Applicant | Biotronik, Inc., Lake Oswego OR, US |
| Decision | Substantially Equivalent, Sep 2, 2021 |
| Received | Jun 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201445
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.