# P180027: Flow Re-Direction Endoluminal Device (FRED®) System

- Pathway: PMA
- Applicant: MicroVention, Inc.
- Decided: Dec 16, 2019 after 502 days
- Product code: OUT (Intracranial Aneurysm Flow Diverter)
- 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 5, 2025 · Class II · Z-0108-2026: Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel 

Source page: https://510kreport.com/device/P180027
Methodology: https://510kreport.com/methodology