Cleared Special

K112007 - CARTO 3 EP NAVIGATION SYSTEM

K112007 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 Special 510(k) pathway after a 83-day FDA review.

K112007 · Biosense Webster, Inc. · Cardiovascular device
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Oct 2011
Decision
83d
Days
Class 2
Risk

K112007 is an FDA 510(k) clearance for the CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2. 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 5, 2011 after a review of 83 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

Submission Details

510(k) Number K112007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2011
Decision Date October 05, 2011
Days to Decision 83 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
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Modification to existing cleared device.

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 K112007.
CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)
K120550 · Biosense Webster, Inc. · May 2012
ENSITE VELOCITY SYSTEM V.3.0
K112688 · St Jude Medical · Nov 2011
MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM
K111200 · Ge Healthcare · Oct 2011
ENSITE VELOCITY SYSTEM
K110549 · St Jude Medical · May 2011
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)
K103746 · Biosense Webster, Inc. · Jan 2011
ENSITE VELOCITY SYSTEM
K101328 · St Jude Medical · Jul 2010