Cleared Special

CARTO? 3 EP Navigation System V9.0 with PIU Plus

K254085 · Biosense Webster, Inc. · Cardiovascular
Jan 2026
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K254085 is an FDA 510(k) clearance for the CARTO? 3 EP Navigation System V9.0 with PIU Plus, 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 January 18, 2026, 31 days after receiving the submission on December 18, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K254085 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2025
Decision Date January 18, 2026
Days to Decision 31 days
Submission Type Special
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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