K-number	K170258
Device name	SpeedLyser Infusion Catheter Kit
Applicant	AngioDynamics, Inc.
Product code	QEY
Device class	Class II
Decision date	Feb 21, 2017
Decision	Substantially Equivalent
Regulation	870.5150

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Source

View the full FDA submission: accessdata.fda.gov

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SpeedLyser Infusion Catheter Kit

Everything you need for a 510(k) submission. Nothing you don't.