# K210685: AcQCross Qx Integrated Transseptal Dilator/Needle

- Pathway: 510(k) (Traditional)
- Applicant: Acutus Medical, Inc.
- Decided: Apr 6, 2021 after 29 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: 5 generations back to K964518 (1997). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193509: AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX, Acutus Medical, Inc. (2020) Summary page 4.

## Most influential descendants
- K233691: FlexCath Cross Transseptal Solution (2023), 0 descendants of its own
- K220047: AcQCross Qx Integrated Transseptal Dilator/Needle (2022), 0 descendants of its own

## Indications for use
The AcQCrossTM 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/K210685
Methodology: https://510kreport.com/methodology