Cleared Traditional

PENTARAY NAV HIGH-DENSITY MAPPING CATHETER (K120425) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K120425 · Biosense Webster, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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

Submission Details

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
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.

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 33
Devices cleared under the same product code (MTD) and FDA review panel - the closest regulatory comparables to K120425.
OptiMap Catheter - 60mm (OPTI-CATH2-60)
K261012 · Cortex, Inc. · Apr 2026
OptiMap Catheter - 50mm (OPTI-CATH2-50)
K253205 · Cortex, Inc. · Mar 2026
Sphere-9Dx Diagnostic Catheter (AFR-00009)
K233433 · Medtronic · Aug 2024
Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™
K241372 · Abbott Medical · Jul 2024
PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID
K231312 · Biosense Webster, Inc. · Jul 2023
Ablacath™ Mapping Catheter
K223666 · Ablacon, Inc. · Mar 2023