# K171557: AcQRef Introducer Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Acutus Medical, Inc.
- Decided: Feb 6, 2018 after 252 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: 7 generations back to K893658 (1989). 53 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043525: Catheter Introducer, Galt Medical Corp. (2005) Summary page 5.
- K103083: Agilis ES Steerable Introducer, St Jude Medical (2011) Summary page 5.

## Most influential descendants
- K192106: AcQRef Introducer Sheath (2019), 0 descendants of its own

## Indications for use
The Acutus Medical AcQRef Introducer Sheath is indicated for use in percutaneous procedures to facilitate venous access from the lower extremities for introduction of catheters and other devices, and may be used to sense intravenous signals.

Source page: https://510kreport.com/device/K171557
Methodology: https://510kreport.com/methodology