Cleared Special

EMBOTRAP III Revascularization Device

K251789 · Neuravi Limited · Neurology

Sep 2025

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K251789 is an FDA 510(k) clearance for the EMBOTRAP III Revascularization Device, a Catheter, Thrombus Retriever (Class II — Special Controls, product code NRY), submitted by Neuravi Limited (Galway, IE). The FDA issued a Cleared decision on September 25, 2025, 106 days after receiving the submission on June 11, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K251789 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 11, 2025
Decision Date	September 25, 2025
Days to Decision	106 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	NRY — Catheter, Thrombus Retriever
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	The Device Is Intended To Restore Blood Flow By Removing Thrombus/clots In Patients Experiencing Ischemic Stroke. The Prior Clearances In This Category Have Been Limited To Simply Identifying Catheter Placed In The Peripheral, Coronary, And Neurovasculature. It Is Felt That This Is A Unique Claim And Should Not Be Combined With Previously Cleared Catheters Under A General Procode.