# K110450: Agilis NXT Steerable Introducer

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: May 10, 2011 after 83 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: 4 generations back to K964518 (1997). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081645: Agilis NXT Steerable Introducer, Model G408324, St Jude Medical (2008) Summary page 1.
- K061363: Agilis NXT Steerable Introducer, St Jude Medical (2006) Summary page 1.

## Most influential descendants
- K210185: CardioCurve Steerable Sheath (2021), 1 descendant of its own
- K240004: CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer (2024), 0 descendants of its own

## Indications for use
The 82cm Agilis NXT™ Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart via the venous anatomy, including the left side of the heart through the interatrial septum

Source page: https://510kreport.com/device/K110450
Methodology: https://510kreport.com/methodology