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FDA 510(k)

UNI*FUSE Infusion System with Cooper Wire

K-Number: K192864 · 2020-06-01

ApplicantAngioDynamics, Inc.
Decision Date2020-06-01
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UNI*FUSE Infusion System with Cooper Wire is a medical device manufactured by AngioDynamics, Inc.. It received FDA 510(k) clearance on 2020-06-01 under approval number K192864. 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 UNI*FUSE Infusion System with Cooper Wire?

UNI*FUSE Infusion System with Cooper Wire is a medical device that received FDA 510(k) clearance on 2020-06-01. It is manufactured by AngioDynamics, Inc.. The 510(k) number is K192864.

When was UNI*FUSE Infusion System with Cooper Wire approved by the FDA?

UNI*FUSE Infusion System with Cooper Wire received FDA 510(k) clearance on 2020-06-01, under approval number K192864.

What company makes UNI*FUSE Infusion System with Cooper Wire?

UNI*FUSE Infusion System with Cooper Wire is manufactured by AngioDynamics, Inc..

What is the FDA product code for UNI*FUSE Infusion System with Cooper Wire?

The FDA product code for UNI*FUSE Infusion System with Cooper Wire 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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