Name: Predicase
Price: 199 USD

K-number	K071253
Device name	AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014
Applicant	Medtronic Vascular
Product code	DTM
Device class	Class II
Decision date	Jul 3, 2007
Decision	Substantially Equivalent
Regulation	870.4260

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Source

View the full FDA submission: accessdata.fda.gov

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AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014

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