510(k) K112007 ยท DQK Computer, Diagnostic, Programmable
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2
| Applicant | Biosense Webster, Inc., Diamond Bar CA, US |
| Decision | Substantially Equivalent, Oct 5, 2011 |
| Received | Jul 14, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112007
| 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 |
| Mar 20, 2012 | Biosense Webster, Inc. CARTO 3 Systems, Product Code M-4800-01
The intended use of the CARTO 3 System is catheter-based cardiac electrophysiological (EP) procedures. Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.