K-number	K150865
Device name	Metacross RX PTA Balloon Dilitation Catheter
Applicant	KANEKA Corporation
Product code	DQY
Device class	Class II
Decision date	Aug 3, 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 RX PTA Balloon Dilitation Catheter

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