K-number	K160919
Device name	Hansen Medical Magellan Robotic Catheter 9Fr
Applicant	Hansen Medical, Inc.
Product code	DRA
Device class	Class II
Decision date	Sep 20, 2016
Decision	Substantially Equivalent
Regulation	870.1280

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Source

View the full FDA submission: accessdata.fda.gov

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Hansen Medical Magellan Robotic Catheter 9Fr

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