Cleared Traditional

K201750 - Pentaray Nav eco High-Density Mapping C...

K201750 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 Traditional 510(k) pathway after a 41-day FDA review.

K201750 · Biosense Webster, Inc. · Cardiovascular device
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Aug 2020
Decision
41d
Days
Class 2
Risk

K201750 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. (Irvin, US). The FDA issued a Cleared decision on August 6, 2020 after a review of 41 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biosense Webster, Inc. devices

Submission Details

510(k) Number K201750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2020
Decision Date August 06, 2020
Days to Decision 41 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
84d faster than avg
Panel avg: 125d · This submission: 41d
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 24
Devices cleared under the same product code (MTD) and FDA review panel - the closest regulatory comparables to K201750.
Reprocessed PentaRay Nav eco High-Density Mapping Catheter
K201806 · Sterilmed Inc. (Johnson and Johnson) · Jun 2021
AcQMap 3D Imaging and Mapping Catheter
K201341 · Acutus Medical, Inc. · Sep 2020
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
K200212 · Innovative Health, LLC · Sep 2020
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