Cleared Special

CARTO 3 EP Navigation System Version 7.2

K213264 · Biosense Webster, Inc. · Cardiovascular
Oct 2021
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K213264 is an FDA 510(k) clearance for the CARTO 3 EP Navigation System Version 7.2, 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 October 29, 2021, 29 days after receiving the submission on September 30, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K213264 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2021
Decision Date October 29, 2021
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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