# K062264: Complete SE Self Expanding Biliary Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Nov 8, 2007 after 461 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 3 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jul 17, 2009 · Not classified · Z-0654-2010: Mislabeling-- A lot of 5 mm x 120 mm stents were labeled as 6 mm x 80 mm stents and vice versa.
- Jul 17, 2009 · Not classified · Z-0655-2010: Mislabeling-- A lot of 5 mm x 12 mm stents were labeled as 6 mm x 80 mm stents and vice versa.
- Nov 24, 2008 · Not classified · Z-0642-2009: Mislabeled: Product may contain wrong instructions for use-- may contain International IFU instead of the correct US (for Biliary indication use only) IFU.

Source page: https://510kreport.com/device/K062264
Methodology: https://510kreport.com/methodology