VariFuse Adjustable Infusion Catheter
FDA 510(k) K251318 · Argon Medical Devices, Inc.
510(k) numberK251318
Submission
- Device name
- VariFuse Adjustable Infusion Catheter
- Applicant
- Argon Medical Devices, Inc.
Athens, TX, US - Received
- April 29, 2025
- Decision date
- January 20, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QEY – Mechanical Thrombolysis Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
To mechanically disrupt thrombus and/or debris in the peripheral vasculature.
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| K202347 | UNIFUSE Infusion System with Cooper WireQEY · Special | AngioDynamics, Inc. | 09/15/2020SE |
| K200648 | EKOS PE Endovascular Device with Control System 4.0 (CS4.0)QEY · Special | Ekos Corporation | 08/17/2020SE |
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Questions and answers
When was VariFuse Adjustable Infusion Catheter cleared by the FDA?
VariFuse Adjustable Infusion Catheter (K251318) received a 510(k) decision of Substantially Equivalent on January 20, 2026, 266 days after the submission was received.
What is the product code of K251318?
The FDA product code is QEY – Mechanical Thrombolysis Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.5150.