Name: Predicase
Price: 199 USD

K-number	K061710
Device name	CPS DIRECT PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLS
Applicant	St Jude Medical
Product code	DQY
Device class	Class II
Decision date	Jul 14, 2006
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 PL PEELABLE OUTER GUIDE CATHETER; ACCESSORY, VALVE BYPASS TOOLS

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