# K140406: Destino Twist, Steerable Guiding Sheath

- Pathway: 510(k) (Special)
- Applicant: Oscor, Inc.
- Decided: Apr 17, 2014 after 58 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 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
- 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

## Recalls of this device
- Dec 22, 2021 · Class II · Z-0646-2022: There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.

## Indications for use
The steerable guiding shdath, model Destino Twist 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/K140406
Methodology: https://510kreport.com/methodology