# K093130: Engage TR Introducer

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Nov 4, 2009 after 30 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K954234 (1995). 16 ancestors in all.
No later device cites it as a predicate yet.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091137: Ultimum/Engage/Engage TR, St Jude Medical (2009) Summary page 1.
- K001346: Ultimum Hemostasis Introducer, Model 4076XX, St. Jude Medical, Inc. (2000) Summary page 2.
- K070166: Strada Carotid Guiding Sheath, St Jude Medical (2007) Summary page 2.
- K914090: Daig Fast Cath (TM) Introducer, Modification, Daig Corp. (1991) Summary page 2.

## Recalls of this device
- Jun 28, 2010 · Not classified · Z-2179-2010: Potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during us
- Jun 28, 2010 · Not classified · Z-2181-2010: Potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during us
- Jun 28, 2010 · Not classified · Z-2180-2010: Potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during us
- Jun 28, 2010 · Not classified · Z-2178-2010: Potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during us
- Jun 28, 2010 · Not classified · Z-2182-2010: Potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during us

## Indications for use
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.

Source page: https://510kreport.com/device/K093130
Methodology: https://510kreport.com/methodology