K-number	K082075
Device name	HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER
Applicant	Hansen Medical, Inc.
Product code	DRE
Device class	Class II
Decision date	Aug 15, 2008
Decision	Substantially Equivalent
Regulation	870.1310

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View the full FDA submission: accessdata.fda.gov

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HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER

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