Cleared Traditional

K132782 - CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2

K132782 is an FDA 510(k) clearance for CARTO3 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 140-day FDA review.

K132782 · Biosense Webster, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
140d
Days
Class 2
Risk

K132782 is an FDA 510(k) clearance for the CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Biosense Webster, Inc. (Diamond Bar, US). The FDA issued a Cleared decision on January 24, 2014 after a review of 140 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 - K132782

510(k) Number K132782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2013
Decision Date January 24, 2014
Days to Decision 140 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
15d slower than avg
Panel avg: 125d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01385202 Completed Interventional Industry-sponsored

THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

172
Patients (actual)
Treatment
Purpose
Open label
Masking
Condition studied Heart Diseases; Arrhythmia; Atrial Fibrillation
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Andrea Natale, MD
Sponsor Biosense Webster, Inc. (industry)
Started 2011-06-01 → Primary completion 2013-02-01 → Completed 2013-05-01
Primary outcome
The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up
Secondary outcome
Rate of Acute Success
View full study on ClinicalTrials.gov

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 350
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K132782.
V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
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MCKESSON CARDIOLOGY ECG MOBILE
K133534 · Mckesson Israel , Ltd. · Apr 2014
EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM
K134044 · Cardio Tek, BV · Mar 2014
RHYTHM VIEW WORKSTATION
K133305 · Topera, Inc. · Dec 2013
MARS HOLTER ANALYSIS WORKSTATION
K132437 · Ge Medical Systems Information Technologies, Inc. · Dec 2013
EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE
K132073 · St Jude Medical · Sep 2013