# K111092: Engage/Engage TR Introducers

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Jun 9, 2011 after 51 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The EngageTM Introducer is indicated for the introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into a blood vessel (including but not limited to femoral, radial, and brachial access) where minimizing blood loss is essential. The Engage TRTM Introducer is indicated for the introduction of angiographic catheters, closed end catheters, balloon catheters, and electrodes into a radial vessel where minimizing blood loss is essential.

Source page: https://510kreport.com/device/K111092
Methodology: https://510kreport.com/methodology