K-number	K061070
Device name	HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR
Applicant	Hansen Medical, Inc.
Product code	DRC
Device class	Class II
Decision date	Oct 13, 2006
Decision	Substantially Equivalent
Regulation	870.1390

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View the full FDA submission: accessdata.fda.gov

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HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR

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