K-number	K120298
Device name	CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE
Applicant	St. Jude Medical, Cardiac Rhythm Management Divisi
Product code	DQX
Device class	Class II
Decision date	May 8, 2012
Decision	Substantially Equivalent
Regulation	870.1330

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Source

View the full FDA submission: accessdata.fda.gov

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CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE

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