# K103083: Agilis ES Steerable Introducer

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Apr 8, 2011 after 171 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: 6 generations back to K893658 (1989). 50 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 53 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.
- K081645: Agilis NXT Steerable Introducer, Model G408324, St Jude Medical (2008) Summary page 1.
- K052575: Luminary Cannulator Bideflectable Catheter with Lumen, St Jude Medical (2006) Summary page 1.

## Most influential descendants
- K171557: AcQRef Introducer Sheath (2018), 1 descendant of its own
- K192106: AcQRef Introducer Sheath (2019), 0 descendants of its own

## Indications for use
The Agilis™ ES Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. The Introducer may be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies.

Source page: https://510kreport.com/device/K103083
Methodology: https://510kreport.com/methodology