# K021630: Boston Scientific Express Biliary LD Premounted Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Oct 25, 2002 after 161 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: 4 generations back to K905720 (1991). 12 ancestors in all.
4 later devices descend from it; 4 cite 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)
- K992755: Cordis Palmaz Corinthian Transhepatic Biliary Stent and Delivery System, Cordis Crimping Tools, Cordis Introducer Tube, Cordis, A Johnson & Johnson Co. (1999) Summary page 1.
- K011889: Ultra -Thin SDS Balloon Dilatation Catheter, Boston Scientific Corp (2001)
- K011909: Ultra-Thin SDS Balloon Dilatation Catheter, Boston Scientific Corp (2001)

## Most influential descendants
- K024048: Modification to Boston Scientific Express Biliary LD Premounted Stent System (2003), 3 descendants of its own
- K030645: Boston Scientific Express Biliary LD Unmounted Stent (2003), 2 descendants of its own
- 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 Premounted Stent System is intended for the palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K021630
Methodology: https://510kreport.com/methodology