510(k) K101018

CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100 by Cardica, Inc. — Product Code FZP

K101018 is an FDA 510(k) premarket notification submitted by Cardica, Inc. for the device "CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100". The FDA issued a decision of Substantially Equivalent on June 25, 2010. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Cardica, Inc. has at least 10 other 510(k) clearances on record.