# P180034: Tack Endovascular System (6F)

- Pathway: PMA
- Applicant: Philips Image Guided Therapy Corporation
- Decided: Apr 11, 2019 after 223 days
- Product code: QCT (Scaffold, Dissection Repair)
- Device class: 3
- Recalls of this device: 1 (1 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
- Jan 10, 2025 · Class I · Z-1070-2025: Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could result in problems with deployment a

Source page: https://510kreport.com/device/P180034
Methodology: https://510kreport.com/methodology