# K190779: Trevo XP ProVue Retriever

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Jun 25, 2019 after 90 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 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K003410 (2001). 8 ancestors in all.
5 later devices descend from it; 2 cite it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173352: Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever), Concentric Medical, Inc. (2018) Summary page 4.
- K120961: Trevo Retriever, Concentric Medical, Inc. (2012) Summary page 4.

## Most influential descendants
- 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
- K223305: Trevo NXT ProVue Retriever (2023), 0 descendants of its own

## Recalls of this device
- Sep 21, 2020 · Class I · Z-0114-2021: Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. The stent retriever can be left behind in the vasculature.

## 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/K190779
Methodology: https://510kreport.com/methodology