# P100022: Zilver PTX Drug-Eluting Peripheral Stent

- Pathway: PMA
- Applicant: Cook Ireland, Ltd.
- Decided: Nov 14, 2012 after 894 days
- Product code: NIU (Stent, Superficial Femoral Artery, Drug-Eluting)
- Device class: 3
- Recalls of this device: 2 (2 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.
1 of 1 device in its family (counting itself) has 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
- Apr 18, 2013 · Class I · Z-1275-2013: Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after s
- Apr 18, 2013 · Class I · Z-1274-2013: Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after s

Source page: https://510kreport.com/device/P100022
Methodology: https://510kreport.com/methodology