Cleared Traditional

K211338 - EMBOTRAP III Revascularization Device (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211338 · Neuravi, Ltd. · Neurology device
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Jul 2021
Decision
88d
Days
Class 2
Risk

K211338 is an FDA 510(k) clearance for the EMBOTRAP III Revascularization Device. Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.

Submitted by Neuravi, Ltd. (Galway, IE). The FDA issued a Cleared decision on July 30, 2021 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1250 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Neuravi, Ltd. devices

Submission Details

510(k) Number K211338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2021
Decision Date July 30, 2021
Days to Decision 88 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 148d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NRY Catheter, Thrombus Retriever
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - NRY Catheter, Thrombus Retriever

All 105
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K211338.
Millipede System
K253590 · Perfuze, Ltd. · Mar 2026
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Zoom System (Zoom 4S Catheter)
K252046 · Imperative Care, Inc. · Oct 2025
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K251603 · Rapid Medical , Ltd. · Oct 2025