Cleared Special

CARTO? 3 EP Navigation System V8.1

K252302 · Biosense Webster, Inc. · Cardiovascular
Aug 2025
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K252302 is an FDA 510(k) clearance for the CARTO? 3 EP Navigation System V8.1, 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 August 22, 2025, 29 days after receiving the submission on July 24, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K252302 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2025
Decision Date August 22, 2025
Days to Decision 29 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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