# K251789: EMBOTRAP III Revascularization Device

- Pathway: 510(k) (Special)
- Applicant: Neuravi Limited
- Decided: Sep 25, 2025 after 106 days
- Product code: NRY (Catheter, Thrombus Retriever)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K003410 (2001). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212908: EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device, Neuravi, Ltd. (2021) Summary page 5.

## Indications for use
The EMBOTRAP III Revascularization Device 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

Source page: https://510kreport.com/device/K251789
Methodology: https://510kreport.com/methodology