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FDA 510(k)

VariFuse Adjustable Infusion Catheter

K-Number: K251318 · 2026-01-20

ApplicantArgon Medical Devices, Inc.
Decision Date2026-01-20
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VariFuse Adjustable Infusion Catheter is a medical device manufactured by Argon Medical Devices, Inc.. It received FDA 510(k) clearance on 2026-01-20 under approval number K251318. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VariFuse Adjustable Infusion Catheter?

VariFuse Adjustable Infusion Catheter is a medical device that received FDA 510(k) clearance on 2026-01-20. It is manufactured by Argon Medical Devices, Inc.. The 510(k) number is K251318.

When was VariFuse Adjustable Infusion Catheter approved by the FDA?

VariFuse Adjustable Infusion Catheter received FDA 510(k) clearance on 2026-01-20, under approval number K251318.

What company makes VariFuse Adjustable Infusion Catheter?

VariFuse Adjustable Infusion Catheter is manufactured by Argon Medical Devices, Inc..

What is the FDA product code for VariFuse Adjustable Infusion Catheter?

The FDA product code for VariFuse Adjustable Infusion Catheter is QEY.

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Related Devices (Code: QEY)

K162777Squirt Fluid Delivery SystemMerit Medical Systems, Inc. K153488Occlusion Perfusion CatheterAdvanced Catheter Therapies, Inc. K163356Pulse* Spray Infusion System, Uni*Fuse Infusion SystemAngioDynamics, Inc. K162771EkoSonic Endovascular System with Control Unit 4.0Btg International, Inc. K170258SpeedLyser Infusion Catheter KitAngioDynamics, Inc. K182324EkoSonic Endovascular SystemBtg International, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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