Cleared Traditional

EmboTrap ll Revascularization Device (K173452) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence.

K173452 · Neuravi, Ltd. · Neurology device
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May 2018
Decision
184d
Days
Class 2
Risk

K173452 is an FDA 510(k) clearance for the EmboTrap ll 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 May 9, 2018 after a review of 184 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Neuravi, Ltd. devices

Submission Details

510(k) Number K173452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2017
Decision Date May 09, 2018
Days to Decision 184 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
36d slower than avg
Panel avg: 148d · This submission: 184d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02488915 Completed Interventional Industry-sponsored

Analysis of Revascularization in Ischemic Stroke With EmboTrap

ARISE II (Analysis of Revascularization in Ischemic Stroke With EmboTrap) Study

228
Patients (actual)
12
Sites
Treatment
Purpose
Open label
Masking
Condition studied Stroke; Ischemia
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Prof. Sam Zaidat, M.D.
Sponsor Neuravi Inc. (industry)
Started 2015-11-01 → Primary completion 2017-05-01 → Completed 2017-09-01
Primary outcome
Successful Revascularization Measured Using Modified Thrombolysis in Cerebrovascular Infarction (mTICI Inclusive of the 2c Rating)
Secondary outcome
Good Clinical Outcome as Defined by Modified Rankin Scale (mRS) Score ≤2
View full study on ClinicalTrials.gov

Regulatory Peers - NRY Catheter, Thrombus Retriever

All 72
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K173452.
Riptide Aspiration System React 68 Catheter
K180705 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Jul 2018
Penumbra System
K180008 · Penumbra, Inc. · Jun 2018
SOFIA Plus Aspiration Catheter
K173200 · MicroVention, Inc. · Jun 2018
Zenith Flex System
K172167 · Inneuroco, Inc. · Apr 2018
AXS Catalyst Distal Access Catheter 058 x 115cm
K173841 · Stryker · Mar 2018
Penumbra 3D Revascularization Device
K162901 · Penumbra, Inc. · Apr 2017