K-number	K092486
Device name	VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT
Applicant	Vortex Medical, Inc.
Product code	DWE
Device class	Class II
Decision date	Aug 28, 2009
Decision	Substantially Equivalent
Regulation	870.4390

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View the full FDA submission: accessdata.fda.gov

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VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT

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