The following data is part of a premarket notification filed by Cardica, Inc. with the FDA for C-port Anastomosis System (deployment System, Clip, Accessories), Model Fg-000050.
| Device ID | K040832 |
| 510k Number | K040832 |
| Device Name: | C-PORT ANASTOMOSIS SYSTEM (DEPLOYMENT SYSTEM, CLIP, ACCESSORIES), MODEL FG-000050 |
| Classification | Clip, Implantable |
| Applicant | CARDICA, INC. 900 SAGINAW DR. Redwood City, CA 94063 |
| Contact | Sevrina Ciucci |
| Correspondent | Sevrina Ciucci CARDICA, INC. 900 SAGINAW DR. Redwood City, CA 94063 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-31 |
| Decision Date | 2005-11-10 |
| Summary: | summary |