# K072202: Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference Patches (Model:D-1283-01)

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: Nov 19, 2007 after 103 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001437 (2000). 10 ancestors in all.
47 later devices descend from it; 2 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013083: Carto XP EP Navigation System, Biosense Webster, Inc. (2001) Summary page 1.
- K060047: Carto RMT EP Navigation System V8, Biosense Webster, Inc. (2006) Summary page 1.
- K982415: Cordis Webster Ref-Star External Reference Patch, Model # D-1210, Cordis Webster, Inc. (1998) Summary page 1.
- K061468: Refstar External Reference Patch, Biosense Webster, Inc. (2006) Summary page 1.
- K060954: Modification to Ensite System, Model EE3000, St. Jude Medical, Inc.-Endocardial Solutions (2006) Summary page 1.

## Most influential descendants
- K090017: Carto 3 EP Navigation System, V1.0 and Accessories (2009), 45 descendants of its own
- K093455: Carto 3 Version 1.05 EP Navigation System and Accessories (2009), 34 descendants of its own
- K103746: Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3 Epnavigation System,Version 2.0 W/RMT Pad) (2011), 33 descendants of its own
- K112007: Carto 3 EP Navigation System, Version 2.2 (2011), 32 descendants of its own
- K120550: Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad) (2012), 31 descendants of its own

## Indications for use
The CARTO® 3 EP Navigation System and accessories are intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time visualization of the catheter as well as display of cardiac maps in a number of different formats. For example, maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed on the System's display screen.

Source page: https://510kreport.com/device/K072202
Methodology: https://510kreport.com/methodology