510(k) K082075

HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER by Hansen Medical, Inc. — Product Code DRE

K082075 is an FDA 510(k) premarket notification submitted by Hansen Medical, Inc. for the device "HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER". The FDA issued a decision of Substantially Equivalent on August 15, 2008. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Hansen Medical, Inc. has at least 10 other 510(k) clearances on record.