510(k) K073304

CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES by Cardica, Inc. — Product Code FZP

K073304 is an FDA 510(k) premarket notification submitted by Cardica, Inc. for the device "CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES". The FDA issued a decision of Substantially Equivalent on December 20, 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2007
Date Received
November 23, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type