Cleared Traditional

CARTO? 3 EP Navigation System V8.4

K252972 · Biosense Webster, Inc. · Cardiovascular
Feb 2026
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K252972 is an FDA 510(k) clearance for the CARTO? 3 EP Navigation System V8.4, 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 20, 2026, 156 days after receiving the submission on September 17, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K252972 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2025
Decision Date February 20, 2026
Days to Decision 156 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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