# K120961: Trevo Retriever

- Pathway: 510(k) (Traditional)
- Applicant: Concentric Medical, Inc.
- Decided: Aug 3, 2012 after 126 days
- Product code: NRY (Catheter, Thrombus Retriever)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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: 4 generations back to K003410 (2001). 5 ancestors in all.
17 later devices descend from it; 2 cite it directly.
1 of 23 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063774: Modification to Merci Retriever, Models X5 and X6, Concentric Medical, Inc. (2007) Summary page 1.

## Most influential descendants
- K122478: Modified Trevo Retriever (2012), 10 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
- K173452: EmboTrap ll Revascularization Device (2018), 4 descendants of its own
- K193063: EMBOTRAP III Revascularization Device (2020), 3 descendants of its own

## Recalls of this device
- Nov 13, 2013 · Class II · Z-0528-2015: Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.

## Indications for use
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.

Source page: https://510kreport.com/device/K120961
Methodology: https://510kreport.com/methodology