# K030645: Boston Scientific Express Biliary LD Unmounted Stent

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Mar 25, 2003 after 25 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- 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 K905720 (1991). 14 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021630: Boston Scientific Express Biliary LD Premounted Stent System, Boston Scientific Corp (2002)
- K024048: Modification to Boston Scientific Express Biliary LD Premounted Stent System, Boston Scientific Scimed, Inc. (2003) Summary page 1.

## Most influential descendants
- K032360: Modification to Boston Scientific Express Biliary LD Premounted Stent System and Express Biliary LD Unmounted Stent (2003), 1 descendant of its own
- K133110: Express LD Biliary Premounted Stent System (2014), 0 descendants of its own

## Indications for use
The Boston Scientific Express™ Biliary LD Unmounted Stent is indicated for use in the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K030645
Methodology: https://510kreport.com/methodology