510(k) K133552

MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT by Hansen Medical — Product Code DRA

K133552 is an FDA 510(k) premarket notification submitted by Hansen Medical for the device "MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT". The FDA issued a decision of Substantially Equivalent on February 7, 2014. The device falls under product code DRA (Catheter, Steerable), a Class II device regulated under 21 CFR 870.1280. Hansen Medical has at least 10 other 510(k) clearances on record.