# P160024: Lifestream Balloon Expandable Vascular Covered Stent

- Pathway: PMA
- Applicant: Bard Peripheral Vascular, Inc.
- Decided: Apr 24, 2017 after 277 days
- Product code: PRL (Iliac Covered Stent, Arterial)
- 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
- Feb 18, 2019 · Class II · Z-0718-2020: Certain product code/lot number combinations may experience introducer sheath compatibility issues when used with a 6F introducer sheath. Using the affected balloon expandable vascular covered stents 

Source page: https://510kreport.com/device/P160024
Methodology: https://510kreport.com/methodology