# P050017: Zilver Vascular Stent

- Pathway: PMA
- Applicant: Cook Ireland, Ltd.
- Decided: Jun 26, 2006 after 437 days
- Product code: NIO (Stent, Iliac)
- Device class: 3
- Recalls of this device: 1 (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. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jan 5, 2012 · Class II · Z-2309-2012: Cook Ireland received a product complaint from Japan on December 22nd, 2011. The complainant reported that a 5 French Zilver Vascular Stent (part number ZIV5-18-125-8-80 from Lot# CF694429) was insert

Source page: https://510kreport.com/device/P050017
Methodology: https://510kreport.com/methodology