# K221044: AcQGuide® VUE Steerable Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Acutus Medical, Inc.
- Decided: May 5, 2022 after 27 days
- Product code: DRA (Catheter, Steerable)
- Device class: 2
- Regulation: 21 CFR 870.1280
- 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 K070357 (2007). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211100: AcQGuide MAX Steerable Sheath, Acutus Medical, Inc. (2021) Summary page 4.

## Indications for use
The AcQGuide® VUE Steerable Sheath with electrodes is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The AcQGuide® VUE deflection facilitates catheter positioning. The electrodes help facilitate visualization of the sheath when used with a compatible localization system, such as the AcQMap System.

Source page: https://510kreport.com/device/K221044
Methodology: https://510kreport.com/methodology