K-number	K052570
Device name	TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221
Applicant	Cardiacassist, Inc.
Product code	DWF
Device class	Class II
Decision date	Jan 17, 2006
Decision	Substantially Equivalent
Regulation	870.4210

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View the full FDA submission: accessdata.fda.gov

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TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221

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