Cleared Traditional

K201341 - AcQMap 3D Imaging and Mapping Catheter

K201341 is the FDA 510(k) clearance for AcQMap 3D Imaging and Mapping Catheter by Acutus Medical, Inc.. It is a Class 2 Cardiovascular device (product code MTD) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K201341 · Acutus Medical, Inc. · Cardiovascular device
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Sep 2020
Decision
118d
Days
Class 2
Risk

K201341 is an FDA 510(k) clearance for the AcQMap 3D Imaging and Mapping Catheter. Classified as Catheter, Intracardiac Mapping, High-density Array (product code MTD), Class II - Special Controls.

Submitted by Acutus Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on September 15, 2020 after a review of 118 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 Acutus Medical, Inc. devices

Submission Details

510(k) Number K201341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2020
Decision Date September 15, 2020
Days to Decision 118 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
7d faster than avg
Panel avg: 125d · This submission: 118d
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 K201341.
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
Reprocessed PentaRay Nav eco High-Density Mapping Catheter
K201806 · Sterilmed Inc. (Johnson and Johnson) · Jun 2021
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
Carto Octaray Mapping Catheter with Trueref Technology
K193237 · Biosense Webster, Inc. · Jul 2020