# K072708: Absolute Pro .035 Self-Expanding Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Vascular-Vascular Solutions
- Decided: Aug 18, 2008 after 328 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: 5 generations back to K980823 (1998). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033393: Absolute .035 Self-Expanding Biliary Stent System, Guidant Corp. (2003) Summary page 1.
- K050501: Modification to: Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System, Abbott Vascular Devices (2005) Summary page 1.

## Indications for use
The Absolute® Pro .035 Biliary Self-Expanding Stent System is intended for palliation of malignant strictures in the biliary tree.

Source page: https://510kreport.com/device/K072708
Methodology: https://510kreport.com/methodology