510(k) K153304

Hansen Medical Magellan Robotic Catheter eKit by Hansen Medical, Inc. — Product Code DRA

K153304 is an FDA 510(k) premarket notification submitted by Hansen Medical, Inc. for the device "Hansen Medical Magellan Robotic Catheter eKit". The FDA issued a decision of Substantially Equivalent on February 1, 2016. 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.