Name: Predicase
Price: 199 USD

K-number	K133552
Device name	MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT
Applicant	Hansen Medical
Product code	DRA
Device class	Class II
Decision date	Feb 7, 2014
Decision	Substantially Equivalent
Regulation	870.1280

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Source

View the full FDA submission: accessdata.fda.gov

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MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT

Everything you need for a 510(k) submission. Nothing you don't.