# P170032: Woven EndoBridge (WEB) Aneurysm Embolization System

- Pathway: PMA
- Applicant: MicroVention, Inc.
- Decided: Dec 31, 2018 after 459 days
- Product code: OPR (Intrasaccular Flow Disruption Device)
- 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 21, 2022 · Class II · Z-0170-2023: Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into the controll

Source page: https://510kreport.com/device/P170032
Methodology: https://510kreport.com/methodology