VariFuse Adjustable Infusion Catheter (K251318): 510(k) cleared Jan 20, 2026

VariFuse Adjustable Infusion Catheter

Argon Medical Devices, Inc. · Jan 20, 2026 · K251318

FDA cleared the VariFuse Adjustable Infusion Catheter from Argon Medical Devices, Inc. on Jan 20, 2026 under K251318, a traditional 510(k). The device falls under product code QEY, Mechanical Thrombolysis Catheter, regulated at 21 CFR 870.5150 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 29, 2025. The decision came 266 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Argon Medical Devices, Inc. has 3 other decisions in the tracker over the last 12 months: K252795 (ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial), K260028 (CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister), K253741 (VStick Vascular Access Set).

Questions & Answers

What did FDA clear under K251318?

K251318 is the FDA 510(k) for VariFuse Adjustable Infusion Catheter, submitted by Argon Medical Devices, Inc.. FDA's decision date was Jan 20, 2026, under product code QEY (Mechanical Thrombolysis Catheter).

Who makes the VariFuse Adjustable Infusion Catheter?

Argon Medical Devices, Inc., based in Athens, TX, is the applicant of record for K251318.

How long did the K251318 review take?

FDA received the submission on Apr 29, 2025 and issued its decision on Jan 20, 2026, 266 days later.

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