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FDA 510(k)

SpeedLyser Infusion Catheter Kit

K-Number: K170258 · 2017-02-21

ApplicantAngioDynamics, Inc.
Decision Date2017-02-21
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SpeedLyser Infusion Catheter Kit is a medical device manufactured by AngioDynamics, Inc.. It received FDA 510(k) clearance on 2017-02-21 under approval number K170258. 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 SpeedLyser Infusion Catheter Kit?

SpeedLyser Infusion Catheter Kit is a medical device that received FDA 510(k) clearance on 2017-02-21. It is manufactured by AngioDynamics, Inc.. The 510(k) number is K170258.

When was SpeedLyser Infusion Catheter Kit approved by the FDA?

SpeedLyser Infusion Catheter Kit received FDA 510(k) clearance on 2017-02-21, under approval number K170258.

What company makes SpeedLyser Infusion Catheter Kit?

SpeedLyser Infusion Catheter Kit is manufactured by AngioDynamics, Inc..

What is the FDA product code for SpeedLyser Infusion Catheter Kit?

The FDA product code for SpeedLyser Infusion Catheter Kit 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. K182324EkoSonic Endovascular SystemBtg International, Inc. K193071Bashir Plus Endovascular CatheterThrombolex, 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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