# K211100: AcQGuide MAX Steerable Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Acutus Medical, Inc.
- Decided: May 14, 2021 after 31 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: 5 generations back to K070357 (2007). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162925: AcQGuide Steerable Sheath, Acutus Medical, Inc. (2017) Summary page 5.

## Most influential descendants
- K221044: AcQGuide® VUE Steerable Sheath (2022), 0 descendants of its own

## Indications for use
The AcQGuide MAX Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The AcQGuide MAX deflection facilitates catheter positioning.

Source page: https://510kreport.com/device/K211100
Methodology: https://510kreport.com/methodology