# K132641: Modified Trevo Provue Retriever

- Pathway: 510(k) (Traditional)
- Applicant: Concentric Medical, Inc.
- Decided: Jan 13, 2014 after 140 days
- Product code: NRY (Catheter, Thrombus Retriever)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K003410 (2001). 7 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122478: Modified Trevo Retriever, Concentric Medical, Inc. (2012) Summary page 1.

## Most influential descendants
- K150616: Trevo XP ProVue Retriever (4x30mm) (2015), 1 descendant of its own
- K143077: Trevo XP ProVue Retriever (6X25mm) (2015), 1 descendant of its own
- K211120: ERIC Retrieval Device (2022), 0 descendants of its own

## Recalls of this device
- Nov 28, 2017 · Class II · Z-0347-2018: Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactured where the carton sleeve did not match the physical contents of the pack.
- 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 Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemnic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IVt-PA) or who fail IV t-PA therapy are candidates for treatment.

Source page: https://510kreport.com/device/K132641
Methodology: https://510kreport.com/methodology