# DEN150049: Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm

- Pathway: De Novo (Direct)
- Applicant: Concentric Medical, Inc.
- Decided: Sep 2, 2016 after 312 days
- Product code: POL (Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment)
- Device class: 2
- Regulation: 21 CFR 882.5600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 2 cite it directly.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K162539: Solitaire 2 Revascularization Device (2016), 9 descendants of its own
- K173352: Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) (2018), 6 descendants of its own
- K190779: Trevo XP ProVue Retriever (2019), 5 descendants of its own
- K192207: Trevo NXT ProVue Retriever (2019), 4 descendants of its own
- K200117: Trevo NXT ProVue Retriever (2020), 3 descendants of its own

## Indications for use
for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.

Source page: https://510kreport.com/device/DEN150049
Methodology: https://510kreport.com/methodology