# K033393: Absolute .035 Self-Expanding Biliary Stent System

- Pathway: 510(k) (Special)
- Applicant: Guidant Corp.
- Decided: Nov 10, 2003 after 18 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002143 (2000). 12 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014184: Modification to Dynalink .035 Biliary Self-Expanding Stent System, Guidant Corp. (2002)
- K021898: Smart Control Nitinol Stent Transhepatic Biliary System, Cordis Corp. (2002) Summary page 1.
- K982346: Angiodynamics Angiostent Biliary Stent System, AngioDynamics, Inc. (1999) Summary page 1.
- K020052: Smart Nitinol Stent Transhepatic Biliary System, Cordis Corp. (2002) Summary page 1.
- K030638: Duramax .035 Biliary Stent System, Models DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML, Avantec Vascular Corp. (2003) Summary page 1.

## Cited in the summary but kept off the family tree
- K020002: Model P-33, Battery Operated, Three Wheel, Power Scooter , Model P-33, Transworld Mobility Distribution, LLC (2002). Our reading of the summary gave K020002, FDA’s number for Model P-33, Battery Operated, Three Wheel, Power Scooter… (Transworld Mobility Distribution, LLC). Its FDA name has none of the distinctive words the summary uses for the device it names, “SMART Therapeutics, Neuroform Microdelivery Stent System”. Kept off the family tree. Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Mar 22, 2006 · Not classified · Z-1082-06: Design : increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent 
- Mar 22, 2006 · Not classified · Z-1080-06: Design : increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent 
- Mar 22, 2006 · Not classified · Z-1084-06: Design : increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent 
- Mar 22, 2006 · Not classified · Z-1083-06: Design : increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent 
- Mar 22, 2006 · Not classified · Z-1085-06: Design : increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent 

## Indications for use
The ABSOLUTE.035 Biliary Self Expanding Stent is intended for palliation of malignant strictures in the biliary tree.

Source page: https://510kreport.com/device/K033393
Methodology: https://510kreport.com/methodology