Cleared Traditional

K261089 - Radical 064 Reperfusion Catheter

Also marketed or referenced as:
Radical 076 Reperfusion Catheter Radical Aspiration Tubing Kit

K261089 is an FDA 510(k) clearance for Radical 064 Reperfusion Catheter, manufactured by Maduro Medical, Inc.. The device is a Class 2 Neurology device with product code NRY cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K261089 · Maduro Medical, Inc. · Neurology device
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Sep 2026
Decision
166d
Days
Class 2
Risk

K261089 is an FDA 510(k) clearance for the Radical 064 Reperfusion Catheter. Classified as Catheter, Thrombus Retriever (product code NRY), Class II - Special Controls.

Submitted by Maduro Medical, Inc. (Los Gatos, US). The FDA issued a Cleared decision on September 14, 2026 after a review of 166 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 Maduro Medical, Inc. devices

FDA 510(k) Submission Details - K261089

510(k) Number K261089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2026
Decision Date September 14, 2026
Days to Decision 166 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
17d slower than avg
Panel avg: 149d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NRY Device Classification - Class 2, Special Controls

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 114
Devices cleared under the same product code (NRY) and FDA review panel - the closest regulatory comparables to K261089.
Tigertriever 13 Ultra Revascularization Device
K260617 · Rapid Medical , Ltd. · Aug 2026
CEREGLIDE 57 Intermediate Catheter
K262398 · Cerenovus, Inc. · Aug 2026
APRO 35 Swift Catheter and Alembic Aspiration Tubing
K262391 · Alembic, LLC · Aug 2026
Millipede System
K262399 · Perfuze, Ltd. · Aug 2026
Socrates Aspiration System (Socrates 70 Aspiration Catheter)
K260002 · Scientia Vascular, Inc. · Jul 2026
Penumbra System (Thunderbolt Aspiration Tubing)
K250690 · Penumbra, Inc. · Jun 2026