Cleared Traditional

K254035 - Mayumi™ Thrombectomy System

K254035 is an FDA 510(k) clearance for Mayumi Thrombectomy System, manufactured by MicroVention, Inc., d/b/a Terumo Neuro. The device is a Class 2 Cardiovascular device with product code QEZ cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K254035 · MicroVention, Inc., d/b/a Terumo Neuro · Cardiovascular device
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Sep 2026
Decision
261d
Days
Class 2
Risk

K254035 is an FDA 510(k) clearance for the Mayumi™ Thrombectomy System. Classified as Aspiration Thrombectomy Catheter (product code QEZ), Class II - Special Controls.

Submitted by MicroVention, Inc., d/b/a Terumo Neuro (Aliso Viejo, US). The FDA issued a Cleared decision on September 3, 2026 after a review of 261 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all MicroVention, Inc., d/b/a Terumo Neuro devices

FDA 510(k) Submission Details - K254035

510(k) Number K254035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2025
Decision Date September 03, 2026
Days to Decision 261 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 125d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QEZ Device Classification - Class 2, Special Controls

Product Code QEZ Aspiration Thrombectomy Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration.
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - QEZ Aspiration Thrombectomy Catheter

All 94
Devices cleared under the same product code (QEZ) and FDA review panel - the closest regulatory comparables to K254035.
Powered Aventus Thrombectomy System™
K261105 · Inquis Medical · Jul 2026
Aventus Thrombectomy System
K262030 · Inquis Medical · Jul 2026
Liberant™ RX Aspiration Catheter
K253589 · Medtronic Interventional Vascular, Inc. · Apr 2026
FLOWRUNNER Aspiration System
K254208 · Expanse Medical, Inc. · Mar 2026
Aventus Thrombectomy System
K253925 · Inquis Medical · Jan 2026
AlphaVac Multipurpose Mechanical Aspiration System F1885
K252509 · AngioDynamics, Inc. · Nov 2025