Cleared Traditional

CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module

K173977 · Biosense Webster, Inc. · Cardiovascular
Jun 2018
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K173977 is an FDA 510(k) clearance for the CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module, 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 June 14, 2018, 167 days after receiving the submission on December 29, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K173977 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2017
Decision Date June 14, 2018
Days to Decision 167 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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