Cleared Traditional

K070240 - CARTO XP EP NAVIGATION SYSTEM, VERSION 9

K070240 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 Traditional 510(k) pathway after a 99-day FDA review.

K070240 · Biosense Webster, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
99d
Days
Class 2
Risk

K070240 is an FDA 510(k) clearance for the CARTO XP EP NAVIGATION SYSTEM, VERSION 9. 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 May 4, 2007 after a review of 99 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 - K070240

510(k) Number K070240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2007
Decision Date May 04, 2007
Days to Decision 99 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
26d faster than avg
Panel avg: 125d · This submission: 99d
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 373
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K070240.
EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM
K071348 · Mennen Medical , Ltd. · Sep 2007
CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR
K071911 · Innovision A/S · Sep 2007
VENDYS MODEL 5000 B/BC
K060980 · Endothelix, Inc. · Aug 2007
MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000
K070902 · St Jude Medical · May 2007
HORIZON SE
K070254 · Mennen Medical , Ltd. · Apr 2007
EP-WORKMATE
K070706 · Ep Medsystems · Apr 2007