Cleared Traditional

K180238 - CARTO 3 EP Navigation System

K180238 is an FDA 510(k) clearance for CARTO 3 EP Navigation System, manufactured by Biosense Webster, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K180238 · Biosense Webster, Inc. · Cardiovascular device
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Jun 2018
Decision
123d
Days
Class 2
Risk

K180238 is an FDA 510(k) clearance for the CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT. 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 June 1, 2018 after a review of 123 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

FDA 510(k) Submission Details - K180238

510(k) Number K180238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2018
Decision Date June 01, 2018
Days to Decision 123 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
2d faster than avg
Panel avg: 125d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

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 280
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K180238.
Epiphany Cardio Server Mobile
K181720 · Epiphany Healthcare, LLC · Jul 2018
RHYTHMIA HDx Mapping System (with software Version 2.0)
K173837 · Boston Scientific Corporation · Jul 2018
CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module
K173977 · Biosense Webster, Inc. · Jun 2018
EnSite Velocity Cardiac Mapping System v5.2
K172396 · St Jude Medical · Apr 2018
AcQMap High Resolution Imaging and Mapping System
K170948 · Acutus Medical, Inc. · Oct 2017
CARTO 3 EP Navigation System, Version 6.0 and Accessories
K170600 · Biosense Webster, Inc. · Jul 2017