Cleared Traditional

CARTO? 3 EP Navigation System with Signal Processing Unit

K200484 · Biosense Webster, Inc. · Cardiovascular
Nov 2020
Decision
272d
Days
Class 2
Risk

About This 510(k) Submission

K200484 is an FDA 510(k) clearance for the CARTO? 3 EP Navigation System with Signal Processing Unit, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Biosense Webster, Inc. (Irvin, US). The FDA issued a Cleared decision on November 25, 2020, 272 days after receiving the submission on February 27, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K200484 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2020
Decision Date November 25, 2020
Days to Decision 272 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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