# K034061: Modification to Convoy Advanced Delivery Sheath

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Jan 30, 2004 after 30 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: 2 generations back to K964518 (1997). 2 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022067: Convoy Advanced Delivery Sheath, Boston Scientific (2002) Summary page 2.

## Most influential descendants
- K072719: Convoy Advanced Delivery Sheath (2008), 11 descendants of its own
- 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

## Recalls of this device
- Dec 24, 2008 · Not classified · Z-1072-2009: The marker band may detach from the sheath and a clinical failure could result in an embolism.

## Indications for use
The intended use for the Convoy Advanced Delivery Sheath Kit is as follows: The Convoy Advanced Deliver Sheath Kit is intended to facilitate the intracardiac placement of interventional devices.

Source page: https://510kreport.com/device/K034061
Methodology: https://510kreport.com/methodology