Cleared Traditional

VariFuse Adjustable Infusion Catheter

K251318 · Argon Medical Devices, Inc. · Cardiovascular
Jan 2026
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K251318 is an FDA 510(k) clearance for the VariFuse Adjustable Infusion Catheter, a Mechanical Thrombolysis Catheter (Class II — Special Controls, product code QEY), submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on January 20, 2026, 266 days after receiving the submission on April 29, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.

Submission Details

510(k) Number K251318 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2025
Decision Date January 20, 2026
Days to Decision 266 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code QEY — Mechanical Thrombolysis Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature.

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