# K143077: Trevo XP ProVue Retriever (6X25mm)

- Pathway: 510(k) (Traditional)
- Applicant: Concentric Medical, Inc.
- Decided: Apr 6, 2015 after 161 days
- Product code: NRY (Catheter, Thrombus Retriever)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K003410 (2001). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132641: Modified Trevo Provue Retriever, Concentric Medical, Inc. (2014) Summary page 4.

## Most influential descendants
- K211120: ERIC Retrieval Device (2022), 0 descendants of its own

## Recalls of this device
- Nov 3, 2017 · Class II · Z-0275-2018: Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical c
- Nov 3, 2017 · Class II · Z-0276-2018: Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical c
- Nov 3, 2017 · Class II · Z-0277-2018: Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical c

## Indications for use
The Trevo XP ProVue Retriever (6x25 mm) 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.

Source page: https://510kreport.com/device/K143077
Methodology: https://510kreport.com/methodology