# K123334: Reprocessed Steerable Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Sustainability Solutions, Inc.
- Decided: Jan 24, 2013 after 90 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.
No later device cites it as a predicate yet.
0 of 7 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.

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

Source page: https://510kreport.com/device/K123334
Methodology: https://510kreport.com/methodology