Name: Predicase
Price: 199 USD

K-number	K090869
Device name	MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD
Applicant	Medtronic Perfusion Systems
Product code	DWF
Device class	Class II
Decision date	Aug 27, 2009
Decision	Substantially Equivalent
Regulation	870.4210

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Source

View the full FDA submission: accessdata.fda.gov

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MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD

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