# K090114: Modification to:Introducer Sets, Model Adelante and Adelante-S

- Pathway: 510(k) (Special)
- Applicant: Oscor, Inc.
- Decided: Jun 4, 2009 after 134 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.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices 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.

## Most influential descendants
- K101497: Delivery Sheath, Model Adelante Breezeway (2010), 8 descendants of its own
- K120459: Steerable Guiding Sheath, Model Adelante Destino (2012), 7 descendants of its own
- K151951: Destino Reach (2015), 6 descendants of its own
- K240829: AuST Steerable Sheath (2024), 5 descendants of its own
- K242106: AuST Steerable Sheath (2024), 4 descendants of its own

## Indications for use
The Introducer sets, models Adelante Sigma, Adelante Sigma AT and Adelante Targa are indicated for the introduction of pacing leads and catheters into the body.

Source page: https://510kreport.com/device/K090114
Methodology: https://510kreport.com/methodology