# K133916: Carto 3 EP Navigation System, Version 4.2

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: Jul 1, 2014 after 190 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K001437 (2000). 22 ancestors in all.
27 later devices descend from it; 6 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120550: Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad), Biosense Webster, Inc. (2012) Summary page 1.

## Most influential descendants
- K170600: CARTO 3 EP Navigation System, Version 6.0 and Accessories (2017), 20 descendants of its own
- K180238: CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT (2018), 19 descendants of its own
- K191660: CARTO 3 EP Navigation System, Version 7.1 and Accessories (2019), 16 descendants of its own
- K200484: CARTO® 3 EP Navigation System with Signal Processing Unit (2020), 15 descendants of its own
- K213264: CARTO 3 EP Navigation System Version 7.2 (2021), 14 descendants of its own

## Recalls of this device
- Aug 15, 2016 · Class II · Z-2776-2016: Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical S
- Sep 10, 2015 · Class II · Z-0002-2016: Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of t

## Indications for use
The intended use of the CARTO 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications.

Source page: https://510kreport.com/device/K133916
Methodology: https://510kreport.com/methodology