# K220047: AcQCross Qx Integrated Transseptal Dilator/Needle

- Pathway: 510(k) (Traditional)
- Applicant: Acutus Medical, Inc.
- Decided: Feb 8, 2022 after 34 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- 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 K964518 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210685: AcQCross Qx Integrated Transseptal Dilator/Needle, Acutus Medical, Inc. (2021) Summary page 4.

## Indications for use
The AcQCross™ Qx Integrated Transseptal Dilator/Needle is indicated to puncture the interatrial septum to gain access to the left side of the heart whereby various cardiovascular catheters are introduced.

Source page: https://510kreport.com/device/K220047
Methodology: https://510kreport.com/methodology