Cleared Traditional

K170600 - CARTO 3 EP Navigation System

K170600 is the FDA 510(k) clearance for CARTO 3 EP Navigation System by Biosense Webster, Inc.. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K170600 · Biosense Webster, Inc. · Cardiovascular device
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Jul 2017
Decision
146d
Days
Class 2
Risk

K170600 is an FDA 510(k) clearance for the CARTO 3 EP Navigation System, Version 6.0 and Accessories. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Biosense Webster, Inc. (Irvin, US). The FDA issued a Cleared decision on July 25, 2017 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Biosense Webster, Inc. devices

Submission Details

510(k) Number K170600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2017
Decision Date July 25, 2017
Days to Decision 146 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 125d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 229
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K170600.
CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module
K173977 · Biosense Webster, Inc. · Jun 2018
CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT
K180238 · Biosense Webster, Inc. · Jun 2018
EnSite Velocity Cardiac Mapping System v5.2
K172396 · St Jude Medical · Apr 2018
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable
K163381 · Edwards Lifesciences, LLC · Apr 2017
RHYTHMIA HDx Mapping System
K162793 · Boston Scientific Corporation · Mar 2017
EnSite Precision Cardiac Mapping System v2.0
K160210 · St Jude Medical · Dec 2016