Cleared Special

K123837 - PENTARAY NAV ECO HIGH-DENSITY MAPPING C...

K123837 is the FDA 510(k) clearance for PENTARAY NAV ECO HIGH-DENSITY MAPPING C... by Biosense Webster, Inc.. It is a Class 2 Cardiovascular device (product code MTD) cleared through the Special 510(k) pathway after a 82-day FDA review.

K123837 · Biosense Webster, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2013
Decision
82d
Days
Class 2
Risk

K123837 is an FDA 510(k) clearance for the PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER. Classified as Catheter, Intracardiac Mapping, High-density Array (product code MTD), Class II - Special Controls.

Submitted by Biosense Webster, Inc. (Diamond Bar, US). The FDA issued a Cleared decision on March 5, 2013 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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 K123837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2012
Decision Date March 05, 2013
Days to Decision 82 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
43d faster than avg
Panel avg: 125d · This submission: 82d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MTD Catheter, Intracardiac Mapping, High-density Array
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
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 - MTD Catheter, Intracardiac Mapping, High-density Array

All 24
Devices cleared under the same product code (MTD) and FDA review panel - the closest regulatory comparables to K123837.
Carto Octaray Mapping Catheter with Trueref Technology
K193237 · Biosense Webster, Inc. · Jul 2020
Advisor HD Grid Mapping Catheter, Sensor Enabled
K172393 · St. Jude Medical, Inc. · Apr 2018
CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER
K140733 · Boston Scientific Corporation · Apr 2014
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
K120425 · Biosense Webster, Inc. · May 2012
ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER
K121006 · St Jude Medical · May 2012
FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING)
K050217 · Biosense Webster, Inc. · Mar 2005