K-number	K170941
Device name	RX NC Takeru PTCA Balloon Dilatation Catheter
Applicant	KANEKA Corporation
Product code	LOX
Device class	Class II
Decision date	Jul 7, 2017
Decision	Substantially Equivalent
Regulation	870.5100

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Source

View the full FDA submission: accessdata.fda.gov

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RX NC Takeru PTCA Balloon Dilatation Catheter

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