# K030638: Duramax .035 Biliary Stent System, Models DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML

- Pathway: 510(k) (Traditional)
- Applicant: Avantec Vascular Corp.
- Decided: Jul 9, 2003 after 131 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 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) Cordis PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035 Delivery System: named in the summary without a submission number

## Most influential descendants
- K033393: Absolute .035 Self-Expanding Biliary Stent System (2003), 3 descendants of its own
- K072720: Alimaxx-B Uncovered Biliary Stent System (2008), 1 descendant of its own
- K093947: Alimaxx-B Uncovered Biliary Stent System Endoscopic (2010), 0 descendants of its own
- K072708: Absolute Pro .035 Self-Expanding Stent System (2008), 0 descendants of its own

## Indications for use
The DuraMaxTM.035 Biliary Stent System is indicated for palliation of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K030638
Methodology: https://510kreport.com/methodology