K-number	K152740
Device name	Radifocus Glidewire
Applicant	Ashitaka Factory of Terumo Corp.
Product code	DQX
Device class	Class II
Decision date	Nov 16, 2015
Decision	Substantially Equivalent
Regulation	870.1330

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View the full FDA submission: accessdata.fda.gov

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Radifocus Glidewire

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