510(k) K090017 ยท DQK Computer, Diagnostic, Programmable
CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES
| Applicant | Biosense Webster, Inc., Diamond Bar CA, US |
| Decision | Substantially Equivalent, Oct 13, 2009 |
| Received | Jan 2, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090017
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2012 | Biosense Webster, Inc. CARTO 3 V1.05(FG-5400-00).
The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different 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 |
| Mar 28, 2011 | Biosense Webster, Inc. 10 ft. Interface Cable, 10 Pin - Shielded Tip Pins to 12 Pin - Blue, Manufacturing Part Number 01287-09, Catalog Number D128709.
This cable is used to connect an Auto 10 10-pole catheter to an EP reco Terminated |
DQK | None listed |
| Jan 7, 2011 | Biosense Webster, Inc. CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catalog Number CR3410CT
This product provides a signal interface between a Biosense Webster electrophysiology cathe Terminated |
DSA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.