# K203219: Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Neurovascular
- Decided: Dec 29, 2020 after 57 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
Longest line of descent: 8 generations back to K003410 (2001). 11 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K190779: Trevo XP ProVue Retriever, Stryker (2019) Summary page 5.
- K200117: Trevo NXT ProVue Retriever, Stryker (2020) Summary page 5.

## Most influential descendants
- K210502: Trevo NXT ProVue Retriever (2021), 1 descendant of its own
- K223305: Trevo NXT ProVue Retriever (2023), 0 descendants of its own

## 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)-MI 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/K203219
Methodology: https://510kreport.com/methodology