K-number	K082199
Device name	SPIRALFUSE PERIPHERAL INFUSION SYSTEM
Applicant	Bacchus Vascular, Inc.
Product code	QEY
Device class	Class II
Decision date	Oct 17, 2008
Decision	Substantially Equivalent
Regulation	870.5150

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View the full FDA submission: accessdata.fda.gov

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SPIRALFUSE PERIPHERAL INFUSION SYSTEM

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