K-number	K172520
Device name	CRE RX Biliary Balloon Dilatation Catheter
Applicant	Boston Scientific Corporation
Product code	FGE
Device class	Class II
Decision date	Oct 4, 2017
Decision	Substantially Equivalent
Regulation	876.5010

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Source

View the full FDA submission: accessdata.fda.gov

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CRE RX Biliary Balloon Dilatation Catheter

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