# P210032: GORE TAG Thoracic Branch Endoprosthesis (TBE Device)

- Pathway: PMA
- Applicant: W. L. Gore & Associates, Inc.
- Decided: May 13, 2022 after 262 days
- Product code: MIH (System, Endovascular Graft, Aortic Aneurysm Treatment)
- 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
- May 19, 2026 · Class II · Z-2672-2026: Due to catheter separation

Source page: https://510kreport.com/device/P210032
Methodology: https://510kreport.com/methodology