# K162925: AcQGuide Steerable Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Acutus Medical, Inc.
- Decided: Apr 6, 2017 after 169 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: 4 generations back to K070357 (2007). 4 ancestors in all.
2 later devices descend 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)
- K123591: Flexcath Advance Steerable Sheath (12 French), Medtronic Cryocath, LP (2012) Summary page 5.

## Most influential descendants
- K211100: AcQGuide MAX Steerable Sheath (2021), 1 descendant of its own
- K221044: AcQGuide® VUE Steerable Sheath (2022), 0 descendants of its own

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

Source page: https://510kreport.com/device/K162925
Methodology: https://510kreport.com/methodology