K-number	K151925
Device name	Elation Wireguided Balloon Dilation Catheter
Applicant	Merit Medical Systems, Inc.
Product code	FGE
Device class	Class II
Decision date	Nov 6, 2015
Decision	Substantially Equivalent
Regulation	876.5010

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Source

View the full FDA submission: accessdata.fda.gov

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Elation Wireguided Balloon Dilation Catheter

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