510(k) Premarket Notification

• Device Classification Name: clip, implantable
• 510(K) Number: K040832
• Device Name: C-PORT ANASTOMOSIS SYSTEM (DEPLOYMENT SYSTEM, CLIP, ACCESSORIES), MODEL FG-000050
• Applicant: CARDICA, INC.; 900 saginaw dr.; redwood city, CA 94063
• Contact: sevrina ciucci
• Regulation Number: 878.4300
• Classification Product Code: FZP
• Date Received: 03/31/2004
• Decision Date: 11/10/2005
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: General & Plastic Surgery
• Review Advisory Committee: Cardiovascular
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No