# K251051: AuST Steerable Sheath

- Pathway: 510(k) (Special)
- Applicant: CenterPoint Systems, LLC
- Decided: Apr 30, 2025 after 27 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: 10 generations back to K893658 (1989). 67 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242106: AuST Steerable Sheath, CenterPoint Systems, LLC (2024) Summary page 5.

## Most influential descendants
- K260942: AuST Steerable Sheath (2026), 1 descendant of its own
- K261492: FieldFlex Steerable Sheath (2026), 0 descendants of its own
- K260163: AuST CSP Introducer (2026), 0 descendants of its own

## Indications for use
The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.

Source page: https://510kreport.com/device/K251051
Methodology: https://510kreport.com/methodology