Cleared Traditional

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

K231207 · Biosense Webster, Inc. · Cardiovascular
Sep 2023
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K231207 is an FDA 510(k) clearance for the CARTO? 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U), 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 September 7, 2023, 133 days after receiving the submission on April 27, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K231207 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2023
Decision Date September 07, 2023
Days to Decision 133 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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