K-number	K861847
Device name	ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE
Applicant	Advanced Cardiovascular Systems, Inc.
Product code	LOX
Device class	Class II
Decision date	Jun 16, 1986
Decision	Substantially Equivalent
Regulation	870.5100

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View the full FDA submission: accessdata.fda.gov

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ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE

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