Cleared Traditional

Reprocessed PentaRay Nav eco High-Density Mapping Catheter (K201806) - FDA 510(k) Clearance

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

K201806 · Sterilmed Inc. (Johnson and Johnson) · Cardiovascular device
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Jun 2021
Decision
357d
Days
Class 2
Risk

K201806 is an FDA 510(k) clearance for the Reprocessed PentaRay Nav eco High-Density Mapping Catheter. Classified as Catheter, Intracardiac Mapping, High-density Array (product code MTD), Class II - Special Controls.

Submitted by Sterilmed Inc. (Johnson and Johnson) (Plymouth, US). The FDA issued a Cleared decision on June 23, 2021 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sterilmed Inc. (Johnson and Johnson) devices

Submission Details

510(k) Number K201806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2020
Decision Date June 23, 2021
Days to Decision 357 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
232d slower than avg
Panel avg: 125d · This submission: 357d
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 20
Devices cleared under the same product code (MTD) and FDA review panel - the closest regulatory comparables to K201806.
OPTRELL™ Mapping Catheter with TRUEref™ Technology
K230253 · Biosense Webster, Inc. · Mar 2023
AcQMap 3D Imaging and Mapping Catheter, Model 900009
K210766 · Acutus Medical, Inc. · Jun 2022
OPTRELL Mapping Catheter with TRUEref Technology
K211438 · Biosense Webster, Inc. · Mar 2022
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
Pentaray Nav eco High-Density Mapping Catheter
K201750 · Biosense Webster, Inc. · Aug 2020