# K120459: Steerable Guiding Sheath, Model Adelante Destino

- Pathway: 510(k) (Traditional)
- Applicant: Oscor, Inc.
- Decided: Jun 29, 2012 after 135 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: 5 generations back to K964518 (1997). 25 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101497: Delivery Sheath, Model Adelante Breezeway, Oscor, Inc. (2010) Summary page 1.
- K081645: Agilis NXT Steerable Introducer, Model G408324, St Jude Medical (2008) Summary page 1.
- K102176: Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model 3FC12, 3FC10, Medtronic Cryocath, LP (2010) Summary page 1.

## Most influential descendants
- 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
- K251051: AuST Steerable Sheath (2025), 3 descendants of its own
- K260942: AuST Steerable Sheath (2026), 1 descendant of its own

## Indications for use
The steerable guiding sheath, model Adelante Destino is intended to facilitate the intracardiac placement of diagnostic and therapeutic devices.

Source page: https://510kreport.com/device/K120459
Methodology: https://510kreport.com/methodology