Cleared Traditional

K120425 - PENTARAY NAV HIGH-DENSITY MAPPING CATHETER

K120425 is an FDA 510(k) clearance for PENTARAY NAV HIGH-DENSITY MAPPING CATHETER, manufactured by Biosense Webster, Inc.. The device is a Class 2 Cardiovascular device with product code MTD cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K120425 · Biosense Webster, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 2012
Decision
101d
Days
Class 2
Risk

K120425 is an FDA 510(k) clearance for the PENTARAY NAV 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 May 24, 2012 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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 - K120425

510(k) Number K120425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2012
Decision Date May 24, 2012
Days to Decision 101 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
24d faster than avg
Panel avg: 125d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MTD Device Classification - Class 2, Special Controls

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 31
Devices cleared under the same product code (MTD) and FDA review panel - the closest regulatory comparables to K120425.
CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER
K140733 · Boston Scientific Corporation · Apr 2014
FIRMAP CATHETER
K130827 · Topera, Inc. · Oct 2013
PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
K123837 · Biosense Webster, Inc. · Mar 2013
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
CONSTELLATION CATHETERS, MODEL 8031M
K021232 · Boston Scientific Corp · May 2002