# P140002: Misago Peripheral Self-Expanding Stent System

- Pathway: PMA
- Applicant: Terumo Medical Corporation
- Decided: May 22, 2015 after 442 days
- Product code: NIP (Stent, Superficial Femoral Artery)
- 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
- Aug 4, 2016 · Class II · Z-0669-2017: During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product specification related to stent diameter at the proximal/distal ends and/or the shape of the stent.

Source page: https://510kreport.com/device/P140002
Methodology: https://510kreport.com/methodology