Cleared Traditional

CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)

K221112 · Biosense Webster, Inc. · Cardiovascular
Aug 2022
Decision
124d
Days
Class 2
Risk

About This 510(k) Submission

K221112 is an FDA 510(k) clearance for the CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM), 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 17, 2022, 124 days after receiving the submission on April 15, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K221112 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2022
Decision Date August 17, 2022
Days to Decision 124 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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