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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 the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2020-09-15 under 510(k) 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. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K202347.

When did UNIFUSE Infusion System with Cooper Wire receive FDA 510(k) clearance?

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

Who is the listed applicant for UNIFUSE Infusion System with Cooper Wire?

The FDA 510(k) record lists AngioDynamics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: 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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