510(k) K151463

Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components by Hansen Medical, Inc. — Product Code DRA

K151463 is an FDA 510(k) premarket notification submitted by Hansen Medical, Inc. for the device "Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components". The FDA issued a decision of Substantially Equivalent on August 18, 2015. The device falls under product code DRA (Catheter, Steerable), a Class II device regulated under 21 CFR 870.1280. Hansen Medical, Inc. has at least 10 other 510(k) clearances on record.