510(k) K061070

HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR by Hansen Medical, Inc. — Product Code DRC

K061070 is an FDA 510(k) premarket notification submitted by Hansen Medical, Inc. for the device "HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR". The FDA issued a decision of Substantially Equivalent on October 13, 2006. The device falls under product code DRC (Trocar), a Class II device regulated under 21 CFR 870.1390. Hansen Medical, Inc. has at least 10 other 510(k) clearances on record.