# K200484: CARTO® 3 EP Navigation System with Signal Processing Unit

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: Nov 25, 2020 after 272 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: 15 generations back to K001437 (2000). 26 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191660: CARTO 3 EP Navigation System, Version 7.1 and Accessories, Biosense Webster, Inc. (2019) Summary page 4.

## Most influential descendants
- 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
- K231207: CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) (2023), 5 descendants of its own
- K241828: Affera Integrated Mapping System; Impedance Localization Patch Kit (2024), 4 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/K200484
Methodology: https://510kreport.com/methodology