510(k) K090872

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

K090872 is an FDA 510(k) premarket notification submitted by Cardica, Inc. for the device "MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM". The FDA issued a decision of Substantially Equivalent on April 21, 2009. 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.