Cleared Traditional

CARTO? 3 EP Navigation System with CARTOSOUND? 4D Version 7.4

K223733 · Biosense Webster, Inc. · Cardiovascular
Feb 2023
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K223733 is an FDA 510(k) clearance for the CARTO? 3 EP Navigation System with CARTOSOUND? 4D Version 7.4, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Biosense Webster, Inc. (Irvine, US). The FDA issued a Cleared decision on February 16, 2023, 65 days after receiving the submission on December 13, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K223733 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2022
Decision Date February 16, 2023
Days to Decision 65 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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