510(k) K063644

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

K063644 is an FDA 510(k) premarket notification submitted by Cardica, Inc. for the device "CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM". The FDA issued a decision of Substantially Equivalent on January 11, 2007. 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.