# K122960: Steerable Guiding Sheath, Model Adelante Destino

- Pathway: 510(k) (Traditional)
- Applicant: Oscor, Inc.
- Decided: Dec 13, 2012 after 79 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: 6 generations back to K893658 (1989). 39 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061119: Enpath Medical Steerable Sheath, Enpath Medical, Inc. (2006) Summary page 1.
- K081049: Flexcath Steerable Sheath & Dilator, Models 3FC10, 3FC12, Cryocath Technologies, Inc. (2008) Summary page 1.

## Cited in the summary but kept off the family tree
- K1212541: Boston Scientific Z flex 270 Steerable Sheath. Number could not be read

## 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 for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.

Source page: https://510kreport.com/device/K122960
Methodology: https://510kreport.com/methodology