Name: Predicase
Price: 199 USD

K-number	K013084
Device name	AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T
Applicant	Medtronic Perfusion Systems
Product code	DTM
Device class	Class II
Decision date	Sep 27, 2001
Decision	Substantially Equivalent
Regulation	870.4260

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Source

View the full FDA submission: accessdata.fda.gov

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AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T

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