# P170013: Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.

- Pathway: PMA
- Applicant: MicroVention, Inc.
- Decided: May 30, 2018 after 425 days
- Product code: QCA (Intracranial Coil-Assist Stent)
- Device class: 3
- Recalls of this device: 2 (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
- Apr 6, 2026 · Class II · Z-2200-2026: Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wal
- Dec 11, 2024 · Class II · Z-1121-2025: Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.

Source page: https://510kreport.com/device/P170013
Methodology: https://510kreport.com/methodology