Name: Predicase
Price: 199 USD

K-number	K120296
Device name	CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER
Applicant	St. Jude Medical, Cardiac Rhythm Management Divisi
Product code	DQY
Device class	Class II
Decision date	May 11, 2012
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER

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