Cleared Special

K013083 - CARTO XP EP NAVIGATION SYSTEM

K013083 is an FDA 510(k) clearance for CARTO XP EP NAVIGATION SYSTEM, manufactured by Biosense Webster, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Special 510(k) pathway after a 68-day FDA review.

K013083 · Biosense Webster, Inc. · Cardiovascular device
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Nov 2001
Decision
68d
Days
Class 2
Risk

K013083 is an FDA 510(k) clearance for the CARTO XP EP NAVIGATION SYSTEM. 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 November 21, 2001 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biosense Webster, Inc. devices

FDA 510(k) Submission Details - K013083

510(k) Number K013083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2001
Decision Date November 21, 2001
Days to Decision 68 days
Submission Type Special
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
57d faster than avg
Panel avg: 125d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

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 359
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K013083.
MAC-LAB/CARDIOLAB EP/COMBOLAB
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K012206 · Cambridge Heart, Inc. · Oct 2001
CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM
K011324 · Cambridge Heart, Inc. · May 2001
SYNETEC
K002817 · Ela Medical, Inc. · May 2001