# P160021: Gore Viabahn VBX Balloon Expandable Endoprosthesis

- Pathway: PMA
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Jan 27, 2017 after 206 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
- Sep 7, 2021 · Class II · Z-0077-2022: Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.

Source page: https://510kreport.com/device/P160021
Methodology: https://510kreport.com/methodology