# K993392: Bard Memotherm Flexx Biliary Stent

- Pathway: 510(k) (Abbreviated)
- Applicant: C.R. Bard, Inc.
- Decided: Jan 6, 2000 after 90 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.
No later device cites it as a predicate yet.
0 of 1 device 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® Nitinol Stent (Transhepatic Biliary Endoprosthesis): named in the summary without a submission number
- (no number) Symphony™ Nitinol Stent Transhepatic Biliary System: named in the summary without a submission number
- (no number) Medtronic AVE Bridge™ Stent System—Biliary Indication: named in the summary without a submission number
- (no number) SM.AR.T. Stent Transhepatic Biliary Stent: named in the summary without a submission number

## Indications for use
The Bard® memotherm-FLEXX® Biliary Stent is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.

Source page: https://510kreport.com/device/K993392
Methodology: https://510kreport.com/methodology