510(k) K173977 ยท DQK Computer, Diagnostic, Programmable
CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module
| Applicant | Biosense Webster, Inc., Irvin CA, US |
| Decision | Substantially Equivalent, Jun 14, 2018 |
| Received | Dec 29, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173977
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.