# K180238: CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: Jun 1, 2018 after 123 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: 13 generations back to K001437 (2000). 24 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170600: CARTO 3 EP Navigation System, Version 6.0 and Accessories, Biosense Webster, Inc. (2017) Summary page 4.

## Most influential descendants
- 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
- K223733: CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 (2023), 6 descendants of its own
- K233943: Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013) (2024), 5 descendants of its own

## 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/K180238
Methodology: https://510kreport.com/methodology