# K201341: AcQMap 3D Imaging and Mapping Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Acutus Medical, Inc.
- Decided: Sep 15, 2020 after 118 days
- Product code: MTD (Catheter, Intracardiac Mapping, High-Density Array)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K983171 (1999). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170819: AcQMap 3D Imaging and Mapping Catheter, Acutus Medical, Inc. (2017) Summary page 5.

## Most influential descendants
- K210766: AcQMap 3D Imaging and Mapping Catheter, Model 900009 (2022), 0 descendants of its own

## Indications for use
The AcQMap 3D Imaging and Mapping Catheter is intended to be used in the right and left atrial chambers to collect ultrasound data for visualizing the selected chamber and recording electrical impulses in patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

Source page: https://510kreport.com/device/K201341
Methodology: https://510kreport.com/methodology