# K013866: Convoy Advanced Delivery Sheath Kit

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific
- Decided: Dec 14, 2001 after 23 days
- Product code: DBY (Fab, Rhodamine, Antigen, Antiserum, Control)
- Device class: 1
- Regulation: 21 CFR 866.5520
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992309 (1999). 1 ancestor in all.
12 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992309: Introducer Sheath, Vessel Dilator, Boston Scientific Corp (1999) 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.
- Dec 24, 2008 · Not classified · Z-1071-2009: The marker band may detach from the sheath and a clinical failure could result in an embolism.

## Indications for use
The Boston Scientific/EP Technologies Convoy™ Advanced Delivery Sheaths and accessories are designed to facilitate the intracardiac placement of interventional devices. The sheath may be exchanged and used in a transseptal position after transseptal puncture has been obtained using a different sheath.

Source page: https://510kreport.com/device/K013866
Methodology: https://510kreport.com/methodology