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FDA 510(k)

UNIFUSE Infusion System with Cooper Wire

K-Number: K202347 · 2020-09-15

ApplicantAngioDynamics, Inc.
Decision Date2020-09-15
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UNIFUSE Infusion System with Cooper Wire is a medical device manufactured by AngioDynamics, Inc.. It received FDA 510(k) clearance on 2020-09-15 under approval number K202347. 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 UNIFUSE Infusion System with Cooper Wire?

UNIFUSE Infusion System with Cooper Wire is a medical device that received FDA 510(k) clearance on 2020-09-15. It is manufactured by AngioDynamics, Inc.. The 510(k) number is K202347.

When was UNIFUSE Infusion System with Cooper Wire approved by the FDA?

UNIFUSE Infusion System with Cooper Wire received FDA 510(k) clearance on 2020-09-15, under approval number K202347.

What company makes UNIFUSE Infusion System with Cooper Wire?

UNIFUSE Infusion System with Cooper Wire is manufactured by AngioDynamics, Inc..

What is the FDA product code for UNIFUSE Infusion System with Cooper Wire?

The FDA product code for UNIFUSE Infusion System with Cooper Wire is QEY.

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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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