510(k) K133916 ยท DQK Computer, Diagnostic, Programmable
CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2
| Applicant | Biosense Webster, Inc., Diamond Bar CA, US |
| Decision | Substantially Equivalent, Jul 1, 2014 |
| Received | Dec 23, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133916
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2016 | Biosense Webster, Inc. CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3.
The CARTO 3 EP Navigation System is intended to be used in catheter-ba Terminated |
DQK | None listed |
| Oct 1, 2015 | Biosense Webster, Inc. Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps. Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.