# K133464: Modified Trevo Provue Retriever

- Pathway: 510(k) (Special)
- Applicant: Concentric Medical, Inc.
- Decided: Jan 17, 2014 after 66 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: 6 generations back to K003410 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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.

## Recalls of this device
- Apr 23, 2024 · Class II · Z-1903-2024: Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exc

## 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 (IVt-PA) or who fail IV t-PA therapy are candidates for treatment.

Source page: https://510kreport.com/device/K133464
Methodology: https://510kreport.com/methodology