Cleared Traditional

K253590 - Millipede System (FDA 510(k) Clearance)

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

K253590 · Perfuze, Ltd. · Neurology device
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Optimized for regulatory review, auditing and printing
Mar 2026
Decision
119d
Days
Class 2
Risk

K253590 is an FDA 510(k) clearance for the Millipede System. Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.

Submitted by Perfuze, Ltd. (Galway, IE). The FDA issued a Cleared decision on March 16, 2026 after a review of 119 days - within the typical 510(k) review window.

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 Perfuze, Ltd. devices

Submission Details

510(k) Number K253590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2025
Decision Date March 16, 2026
Days to Decision 119 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
29d faster than avg
Panel avg: 148d · This submission: 119d
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
NCT05714501 Completed Interventional Industry-sponsored

Millipede AspiRation for Revascularization in Stroke (MARRS) Study

246
Patients (actual)
23
Sites
Treatment
Purpose
Open label
Masking
Condition studied Acute Ischemic Stroke
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Raul Nogueira, MD
Sponsor Perfuze (industry)
Started 2023-10-09 → Primary completion 2025-03-08 → Completed 2025-05-12
Primary outcome
Proportion of subjects with successful reperfusion, defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater, after ≤3 passes with the Millipede System without additional therapy.
Study completed - no results published. This trial concluded in 2025 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

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 K253590.
Tigertriever 25 Revascularization Device
K253062 · Rapid Medical , Ltd. · Mar 2026
Esperance pHLO Aspiration System
K251357 · Phenox, Ltd. · Jan 2026
NeVasc Aspiration System
K251006 · Vesalio, Inc. · Nov 2025
Zoom System (Zoom 4S Catheter)
K252046 · Imperative Care, Inc. · Oct 2025
Tigertriever 17 Ultra Revascularization Device
K251603 · Rapid Medical , Ltd. · Oct 2025
EMBOTRAP III Revascularization Device
K251789 · Neuravi Limited · Sep 2025