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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 the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2017-02-21 under 510(k) 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. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K170258.

When did SpeedLyser Infusion Catheter Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for SpeedLyser Infusion Catheter Kit?

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 SpeedLyser Infusion Catheter Kit?

The FDA product code for SpeedLyser Infusion Catheter Kit 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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