← Back to catalogue

CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module

FDA 510(k)

Class II (US FDA 510(k))

510(k) K173977

by Biosense Webster Inc

Identifiers

510(k) Number
K173977 FDA 510(k)
FDA Product Code
DQK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1425 FDA 510(k)
Regulation Number
870.1425 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module is a catheter-based atrial and ventricular mapping system designed to acquire and analyze data points and use this information to display 3D anatomical and electro-anatomical maps of the human heart. It acquires intracardiac electrical signals and catheter location data using magnetic sensor technology and Advanced Catheter Location (ACL) technology.

The system is supplied as a reusable navigation platform with associated accessories for use in electrophysiology procedures. It is intended for use in clinical settings to support cardiac mapping during atrial and ventricular procedures. The device received FDA 510(k) clearance under K173977 and is classified under product code DQK with cardiovascular advisory committee review.

Frequently asked questions

What is the CARTO 3 EP Navigation System used for?

The CARTO 3 EP Navigation System is used to acquire and analyze intracardiac electrical signals and catheter location data to create 3D anatomical and electro-anatomical maps of the human heart, supporting cardiac mapping during atrial and ventricular electrophysiology procedures.

How is the CARTO 3 EP Navigation System supplied and is it reusable?

The system is supplied as a reusable navigation platform with associated accessories, meaning the main unit can be used multiple times after proper cleaning and maintenance, while certain accessories may be single-use depending on their design and intended use.

What technology does the CARTO 3 EP Navigation System use to track catheter location?

The system uses magnetic sensor technology and Advanced Catheter Location (ACL) technology to acquire intracardiac electrical signals and precise catheter location data for accurate 3D mapping of cardiac anatomy and electrical activity.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CARTO - The Agentic GIS Platform, CARTO 3 EP Navigation System, Version 4.35 and Accessories with ..., CARTO 3 EP Navigation System, Version 4.35 and Accessories with ..., K173977 - CARTO 3 EP Navigation System | FDA 510 (k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biosense Webster Inc
FDA Applicant
Biosense Webster, Inc.

Sources (1)

  • FDA 510(k) K173977 24 fields · synced Oct 1, 2026