# K042623: Agilis Steerable Catheter Introducer, Model 408304

- Pathway: 510(k) (Special)
- Applicant: St. Jude Medical, Daig Division, Inc.
- Decided: Jan 27, 2005 after 122 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: 1 generation back to K964518 (1997). 2 ancestors in all.
81 later devices descend from it; 4 cite it directly.
2 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964518: Fast-Cath Transseptal Catheter Introducer, Daig Corp. (1997) Summary page 1.
- K973840: Fast-Cath (TM) Intra-Cardiac Introducer, Daig Corp. (1998) Summary page 1.

## Most influential descendants
- K061363: Agilis NXT Steerable Introducer (2006), 53 descendants of its own
- K081645: Agilis NXT Steerable Introducer, Model G408324 (2008), 36 descendants of its own
- K052644: Swartz Braided Transseptal Guiding Introducer (2005), 36 descendants of its own
- K070417: Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984 (2007), 11 descendants of its own
- K061015: Fast-Cath Hemostasis Introducer and Transseptal Introducer (2006), 9 descendants of its own

## Recalls of this device
- Apr 14, 2006 · Not classified · Z-1086-06: St Jude Medical has determined that a limited number of Agilis Steerable Introducers manufactured in late 2005 are susceptible to the hemostasis hub leaking or separating from the handle. The risks th

## Indications for use
The St. Jude Medical (SJM) Agilis TM Steerable Catheter Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septurn.

Source page: https://510kreport.com/device/K042623
Methodology: https://510kreport.com/methodology