Cleared Traditional

K070240 - CARTO XP EP NAVIGATION SYSTEM

K070240 is the FDA 510(k) clearance for CARTO XP EP NAVIGATION SYSTEM by Biosense Webster, Inc.. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K070240 · Biosense Webster, Inc. · Cardiovascular device
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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

Submission Details

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.

Device Classification

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 259
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K070240.
ENSITE FUSION DYNAMIC REGISTRATION TOOL
K071818 · St Jude Medical · Dec 2007
CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01)
K072202 · Biosense Webster, Inc. · Nov 2007
MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM
K072502 · Ge Medical Systems Information Technologies · Nov 2007
MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000
K070902 · St Jude Medical · May 2007
SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810
K063490 · Spacelabs Medical, Inc. · Mar 2007
MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM
K061741 · Ge Healthcare · Sep 2006