# K021994: Bard Conformexx Biliary Stent and Delivery System

- Pathway: 510(k) (Abbreviated)
- Applicant: C.R. Bard, Inc.
- Decided: Jan 2, 2003 after 198 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bard memotherm-FLEXX Biliary Stent: named in the summary without a submission number
- (no number) Bard memotherm Transhepatic Biliary Endoprosthesis: named in the summary without a submission number
- (no number) Bard LUMINEXX 6 Fr Delivery System: named in the summary without a submission number

## Most influential descendants
- K052114: Bard Conformexx Biliary Stent with the Performaxx Grip (2005), 0 descendants of its own

## Indications for use
The Bard CONFORMEXX Biliary Stent and Delivery System is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.

Source page: https://510kreport.com/device/K021994
Methodology: https://510kreport.com/methodology