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FDA 510(k)

Pulse* Spray Infusion System, Uni*Fuse Infusion System

K-Number: K163356 · 2017-05-30

ApplicantAngioDynamics, Inc.
Decision Date2017-05-30
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pulse* Spray Infusion System, Uni*Fuse Infusion System is a medical device manufactured by AngioDynamics, Inc.. It received FDA 510(k) clearance on 2017-05-30 under approval number K163356. 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 Pulse* Spray Infusion System, Uni*Fuse Infusion System?

Pulse* Spray Infusion System, Uni*Fuse Infusion System is a medical device that received FDA 510(k) clearance on 2017-05-30. It is manufactured by AngioDynamics, Inc.. The 510(k) number is K163356.

When was Pulse* Spray Infusion System, Uni*Fuse Infusion System approved by the FDA?

Pulse* Spray Infusion System, Uni*Fuse Infusion System received FDA 510(k) clearance on 2017-05-30, under approval number K163356.

What company makes Pulse* Spray Infusion System, Uni*Fuse Infusion System?

Pulse* Spray Infusion System, Uni*Fuse Infusion System is manufactured by AngioDynamics, Inc..

What is the FDA product code for Pulse* Spray Infusion System, Uni*Fuse Infusion System?

The FDA product code for Pulse* Spray Infusion System, Uni*Fuse Infusion System 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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