# K173352: Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)

- Pathway: 510(k) (Traditional)
- Applicant: Concentric Medical, Inc.
- Decided: Feb 15, 2018 after 113 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN150049 (2016). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Concentric Medical, Inc. (2016) Summary page 4.

## Most influential descendants
- 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
- K203219: Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever (2020), 2 descendants of its own
- K210502: Trevo NXT ProVue Retriever (2021), 1 descendant of its own

## Recalls of this device
- Apr 23, 2024 · Class II · Z-1902-2024: Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exc

## Indications for use
1. The Trevo Retriever is indicated 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. 2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. 3. The Trevo Retriever is indicated 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 of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50 cc for age < 80 years, 0-20 cc for age ≥ 80 years). Endovascular therapy with the device should start within 6-24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

Source page: https://510kreport.com/device/K173352
Methodology: https://510kreport.com/methodology