Cleared Special

K020863 - CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM

K020863 is an FDA 510(k) clearance for CARTO XP AND QWIKMAP 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 297-day FDA review.

K020863 · Biosense Webster, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
297d
Days
Class 2
Risk

K020863 is an FDA 510(k) clearance for the CARTO XP AND QWIKMAP 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 January 9, 2003 after a review of 297 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K020863

510(k) Number K020863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2002
Decision Date January 09, 2003
Days to Decision 297 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
172d slower than avg
Panel avg: 125d · This submission: 297d
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 437
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K020863.
LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0
K031000 · C.R. Bard, Inc. · Jun 2003
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
K030129 · Endocardial Solutions, Inc. · Apr 2003
BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)
K022596 · Clover Hi-Tech, Inc. · Jan 2003
CHEETAH I.V.D.S., MODEL 2002P
K023370 · Cheetah Medical, Inc. · Dec 2002
PROSOLV CARDIVASCULAR VIEWER
K023112 · Problem Solving Concepts, Inc. · Dec 2002
NEWCOR
K020440 · Siemens Medical Systems, Inc. · Dec 2002
K020863 · CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM
Download PDF FDA Summary Biosense Webster, Inc.