# K212908: EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device

- Pathway: 510(k) (Special)
- Applicant: Neuravi, Ltd.
- Decided: Oct 13, 2021 after 30 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: 11 generations back to K003410 (2001). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173452: EmboTrap ll Revascularization Device, Neuravi, Ltd. (2018) Summary page 4.
- K193063: EMBOTRAP III Revascularization Device, Neuravi, Ltd. (2020) Summary page 4.
- K211338: EMBOTRAP III Revascularization Device, Neuravi, Ltd. (2021) Summary page 4.

## Most influential descendants
- K251789: EMBOTRAP III Revascularization Device (2025), 0 descendants of its own

## Indications for use
The EmboTrap II 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 intravenous tissue plasminogen activator (TV t-PA) or who fail IV t-PA therapy are candidates for treatment. 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 intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Source page: https://510kreport.com/device/K212908
Methodology: https://510kreport.com/methodology