510(k) K120550 ยท DQK Computer, Diagnostic, Programmable
CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)
| Applicant | Biosense Webster, Inc., Diamond Bar CA, US |
| Decision | Substantially Equivalent, May 7, 2012 |
| Received | Feb 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120550
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2014 | Biosense Webster, Inc. CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124
WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAYED Terminated |
DQK | None listed |
| Mar 28, 2013 | Biosense Webster, Inc. 20-Pole Eco Cable, Catalog #EM-5050-060
Product Usage:
The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System. Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.