Cleared Traditional

K251318 - VariFuse Adjustable Infusion Catheter (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251318 · Argon Medical Devices, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
266d
Days
Class 2
Risk

K251318 is an FDA 510(k) clearance for the VariFuse Adjustable Infusion Catheter. Classified as Mechanical Thrombolysis Catheter (product code QEY), Class II - Special Controls.

Submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on January 20, 2026 after a review of 266 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 Argon Medical Devices, Inc. devices

Submission Details

510(k) Number K251318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 125d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QEY Mechanical Thrombolysis Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature.
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 - QEY Mechanical Thrombolysis Catheter

All 70
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K251318.
Versus™ Catheter (VS110-9NB)
K260149 · Liquet Medical, Inc. · Feb 2026
Versus™ Catheter (VS110-8B)
K241851 · Liquet Medical, Inc. · Nov 2024
EKOS+ Endovascular Device
K220866 · Boston Scientific · Apr 2022
EkoSonic Endovascular Device, EKOS+ Endovascular Device
K213422 · Boston Scientific Corporation · Dec 2021
EkoSonic Endovascular Device
K211080 · Boston Scientific · Nov 2021