510(k) K191660 ยท DQK Computer, Diagnostic, Programmable
CARTO 3 EP Navigation System, Version 7.1 and Accessories
| Applicant | Biosense Webster, Inc., Irvin CA, US |
| Decision | Substantially Equivalent, Jul 20, 2019 |
| Received | Jun 21, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191660
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2020 | Biosense Webster (israel), Ltd. CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides in Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.