# P180037: Venovo Venous Stent System

- Pathway: PMA
- Applicant: Bard Peripheral Vascular, Inc.
- Decided: Mar 13, 2019 after 180 days
- Product code: QAN (Stent, Iliac Vein)
- Device class: 3
- Recalls of this device: 3 (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
- Dec 14, 2020 · Class II · Z-1899-2021: Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
- Dec 14, 2020 · Class II · Z-1897-2021: Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
- Dec 14, 2020 · Class II · Z-1898-2021: Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.

Source page: https://510kreport.com/device/P180037
Methodology: https://510kreport.com/methodology