K-number	K132972
Device name	AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
Applicant	Medtronic, Inc.
Product code	DTN
Device class	Class II
Decision date	Oct 28, 2013
Decision	Substantially Equivalent
Regulation	870.4400

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View the full FDA submission: accessdata.fda.gov

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AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE

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