K-number	K123351
Device name	AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
Applicant	Medtronic Perfusion Systems
Product code	DTM
Device class	Class II
Decision date	Mar 19, 2013
Decision	Substantially Equivalent
Regulation	870.4260

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Source

View the full FDA submission: accessdata.fda.gov

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AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE

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