510(k) K052742

HEPASPHERE MICROSPHERES by Biosphere Medical, Inc. — Product Code KRD

K052742 is an FDA 510(k) premarket notification submitted by Biosphere Medical, Inc. for the device "HEPASPHERE MICROSPHERES". The FDA issued a decision of Substantially Equivalent on November 7, 2006. The device falls under product code KRD (Device, Vascular, For Promoting Embolization), a Class II device regulated under 21 CFR 870.3300. Biosphere Medical, Inc. has at least 10 other 510(k) clearances on record.