Cleared Traditional

K090017 - CARTO 3 EP NAVIGATION SYSTEM

K090017 is the FDA 510(k) clearance for CARTO 3 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 284-day FDA review.

K090017 · Biosense Webster, Inc. · Cardiovascular device
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Oct 2009
Decision
284d
Days
Class 2
Risk

K090017 is an FDA 510(k) clearance for the CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES. 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 October 13, 2009 after a review of 284 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. 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 K090017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2009
Decision Date October 13, 2009
Days to Decision 284 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
159d slower than avg
Panel avg: 125d · This submission: 284d
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 243
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K090017.
MARS HOLTER ANALYSIS WORKSTATION
K093141 · Ge Medical Systems Information Technologies · Dec 2009
EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE
K093583 · St Jude Medical · Dec 2009
CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES
K093455 · Biosense Webster, Inc. · Dec 2009
EP-WORKMATE SYSTEM, VERSION 4.2
K092810 · St Jude Medical · Oct 2009
CARTO RMT EP NAVIGATION SYSTEM V8
K091789 · Biosense Webster, Inc. · Oct 2009
ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010
K083328 · St Jude Medical · May 2009