Cleared Traditional

K201341 - AcQMap 3D Imaging and Mapping Catheter

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

K201341 · Acutus Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K201341

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.

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 32
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