# P180013: VICI VENOUS STENT System

- Pathway: PMA
- Applicant: Boston Scientific Corporation
- Decided: May 2, 2019 after 371 days
- Product code: QAN (Stent, Iliac Vein)
- 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 12, 2021 · Class I · Z-1592-2021: The firm has received reports of stent migration after implantation
- Apr 12, 2021 · Class I · Z-1591-2021: The firm has received reports of stent migration after implantation

Source page: https://510kreport.com/device/P180013
Methodology: https://510kreport.com/methodology