510(k) K221112 ยท DQK Computer, Diagnostic, Programmable
CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)
| Applicant | Biosense Webster, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Aug 17, 2022 |
| Received | Apr 15, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221112
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.