# P140026: Enroute Transcarotid Stent System

- Pathway: PMA
- Applicant: Boston Scientific Corporation
- Decided: May 18, 2015 after 182 days
- Product code: NIM (Stent, Carotid)
- 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
- Jan 13, 2021 · Class II · Z-1146-2021: Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.

Source page: https://510kreport.com/device/P140026
Methodology: https://510kreport.com/methodology