# P100028: Formula Balloon-Expandable Renal Stent System

- Pathway: PMA
- Applicant: Cook Medical Incorporated
- Decided: Jan 14, 2011 after 179 days
- Product code: NIN (Stent, Renal)
- 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
- Apr 15, 2020 · Class II · Z-1940-2020: The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon delivery system prior to deployment. Use of affected product may lead to increased procedu

Source page: https://510kreport.com/device/P100028
Methodology: https://510kreport.com/methodology