K-number	K152080
Device name	Metacross OTW PTA Balloon Dilatation Catheter
Applicant	KANEKA Corporation
Product code	LIT
Device class	Class II
Decision date	Sep 24, 2015
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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Metacross OTW PTA Balloon Dilatation Catheter

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