# K061363: Agilis NXT Steerable Introducer

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Jul 12, 2006 after 57 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K964518 (1997). 4 ancestors in all.
53 later devices descend from it; 15 cite it directly.
2 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042623: Agilis Steerable Catheter Introducer, Model 408304, St. Jude Medical, Daig Division, Inc. (2005) Summary page 1.
- K022380: Livesire Electrophysiology Catheter, St Jude Medical (2002) Summary page 1.

## Most influential descendants
- K081645: Agilis NXT Steerable Introducer, Model G408324 (2008), 36 descendants of its own
- 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

## Recalls of this device
- Apr 30, 2024 · Class II · Z-2348-2024: One lot of product has dilators that are too short and will not extend outside the introducer sheath.

## Indications for use
The Agilis 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/K061363
Methodology: https://510kreport.com/methodology