# K081645: Agilis NXT Steerable Introducer, Model G408324

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Dec 9, 2008 after 180 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: 3 generations back to K964518 (1997). 5 ancestors in all.
36 later devices descend from it; 16 cite it directly.
2 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061363: Agilis NXT Steerable Introducer, St Jude Medical (2006) Summary page 1.

## Most influential descendants
- K120459: Steerable Guiding Sheath, Model Adelante Destino (2012), 7 descendants of its own
- K151951: Destino Reach (2015), 6 descendants of its own
- K240829: AuST Steerable Sheath (2024), 5 descendants of its own
- K242106: AuST Steerable Sheath (2024), 4 descendants of its own
- K251051: AuST Steerable Sheath (2025), 3 descendants of its own

## Indications for use
The AgilisTM NxT Steerable Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Source page: https://510kreport.com/device/K081645
Methodology: https://510kreport.com/methodology