# K983008: Peripheral Ave Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Peripheral Ave
- Decided: Nov 25, 1998 after 89 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.
18 later devices descend from it; 4 cite it directly.
0 of 19 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) Johnson & Johnson Interventional Systems’ PALMAZ™ Balloon-Expandable Stent: named in the summary without a submission number

## Most influential descendants
- K030053: Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810 (2003), 8 descendants of its own
- K033537: Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, and EX8S3005 (2003), 7 descendants of its own
- K993145: Medtronic Ave Bridge Stent (1999), 6 descendants of its own
- K992569: Medtronic Ave Bridge Stent (1999), 6 descendants of its own
- K011817: Bridge FX (2001), 5 descendants of its own

## Indications for use
The Peripheral AVE Biliary Stent System is intended to maintain patency of biliary duct which is occluded by a malignant tumor.

Source page: https://510kreport.com/device/K983008
Methodology: https://510kreport.com/methodology