K-number	K132556
Device name	SHEATHLESS EAUCATH CORONARY GUIDE CATHETER
Applicant	Asahi Intecc Co., Ltd.
Product code	DQY
Device class	Class II
Decision date	Oct 24, 2013
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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SHEATHLESS EAUCATH CORONARY GUIDE CATHETER

Everything you need for a 510(k) submission. Nothing you don't.