# K090017: Carto 3 EP Navigation System, V1.0 and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: Oct 13, 2009 after 284 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K001437 (2000). 14 ancestors in all.
45 later devices descend from it; 2 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072202: Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference Patches (Model:D-1283-01), Biosense Webster, Inc. (2007) Summary page 1.
- K060047: Carto RMT EP Navigation System V8, Biosense Webster, Inc. (2006) Summary page 1.
- K070240: Carto XP EP Navigation System, Version 9, Biosense Webster, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K133916: Carto 3 EP Navigation System, Version 4.2 (2014), 27 descendants of its own

## Recalls of this device
- Feb 9, 2012 · Not classified · Z-1230-2012: Some CARTO 3 Systems may get radio frequency interference through certain interconnected cable configurations resulting in jumping or disappearing catheter icon and/or error messages during ablation.
- Feb 15, 2011 · Not classified · Z-1839-2011: The recall was initiated because Biosense Webster has confirmed that there is an inaccessibility of electronic version of the instruction for use (e-IFU) for the "10 ft. Interface Cable, 10 Pin-Shield
- Oct 5, 2010 · Not classified · Z-0884-2011: When connecting this cable to the mapping system, loss of Body Surface ECG signals may occur. This may result in inaccurate locations appearing for catheters displayed 3D on the CARTO monitor.
- Nov 17, 2009 · Class II · Z-2369-2012: The recall was initiated because Biosense Webster has become aware of information regarding a potential hazard that may occur during the operation of a Bloom EP Stimulator device in conjunction with R

## Indications for use
The CARTO® 3 V1.0 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 formats. Maps may be displayed as anatomical maps, cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, cardiac chamber geometry maps and ECG fragmentation maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the System's display screen. The CARTO® 3 V1.0 System is also intended to support EP procedures, maintaining CARTO® System capabilities, in the presence of a high metallic environment and magnetic field strengths upto 0.1 T and provide a data communication channel to the Stereotaxis Niobe® Catheter Navigation System. The CARTO® 3 V1.0 System includes CARTOMERGE® PLUS functionality to import, register and merge CT or MRI structural images with CARTO® map's physiological information and real time catheter navigation. The system includes the Fast Anatomical Mapping (FAM) functionality that allows for the quick creation of cardiac anatomical volumes using catheters with magnetic location sensors. The system's CARTOSOUND image integration functionality enables integration of intracardiac echo (ICE) to enable visualization of 3D combined maps. In addition to the use of specialized navigation catheters with magnetic location sensors, the system is also intended for use with conventional, non-navigational, electrophysiology catheters without magnetic location sensors.

Source page: https://510kreport.com/device/K090017
Methodology: https://510kreport.com/methodology