Cleared Special

CARTO 3 EP Navigation System, Version 7.1 and Accessories

K191660 · Biosense Webster, Inc. · Cardiovascular
Jul 2019
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K191660 is an FDA 510(k) clearance for the CARTO 3 EP Navigation System, Version 7.1 and Accessories, 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 July 20, 2019, 29 days after receiving the submission on June 21, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K191660 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2019
Decision Date July 20, 2019
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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