# K162427: Vado Bi-Directional Steerable Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Kalila Medical, Inc.
- Decided: Jan 27, 2017 after 150 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
Longest line of descent: 4 generations back to K964518 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140420: Vado Steerable Sheath, Kalila Medical, Inc. (2014) Summary page 4.
- K061363: Agilis NXT Steerable Introducer, St Jude Medical (2006) Summary page 4.

## Recalls of this device
- Dec 14, 2017 · Class II · Z-0564-2018: Torn sheath liner material was detected at the proximal end of the device during internal product testing which may be the result of damage incurred during the manufacturing process.

## Indications for use
The Vado® Bi-Directional Steerable Sheath is indicated for introducing various cardiovascular catheters into the vasculature and into the chambers of the heart including the left side of the heart through the interatrial septum.

Source page: https://510kreport.com/device/K162427
Methodology: https://510kreport.com/methodology