510(k) · Cardiovascular

CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)

by Biosense Webster, Inc.

CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) is an AI-enabled medical device from Biosense Webster, Inc. that the U.S. FDA cleared through 510(k) K231207 on September 7, 2023. Its lead review panel is Cardiovascular and its primary product code is DQK (Computer, Diagnostic, Programmable).

See also FDA-cleared AI cardiovascular devices in 2023, all FDA AI clearances in 2023, top cardiovascular AI devices.

Key facts

Submission numberK231207
Pathway510(k)
Date of final decision
Company (FDA list)Biosense Webster, Inc.
Lead review panelCardiovascular
Primary product codeDQK — Computer, Diagnostic, Programmable
Applicant (openFDA)Biosense Webster, Inc.
Applicant locationIrvine, CA, US
Device classClass 2
Regulation number21 CFR 870.1425
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) went through this pathway (K231207).

openFDA lists it as a Class 2 device under 21 CFR 870.1425. Class II devices are moderate risk and are subject to general and special controls.

Product code DQK covers 28 devices on the FDA AI list. By decision date, this device is #16 of 28 under that code. Biosense Webster, Inc. has 2 AI-enabled devices on the list, and the Cardiovascular panel accounts for 154 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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