K-number	K180086
Device name	Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter
Applicant	Gyrus Acmi, Inc.
Product code	FGE
Device class	Class II
Decision date	Mar 8, 2018
Decision	Substantially Equivalent
Regulation	876.5010

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Source

View the full FDA submission: accessdata.fda.gov

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Gyrus ACMI  EZDilate 3-Stage Balloon Dilatation Catheter

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Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter