The following data is part of a premarket notification filed by Cardica, Inc. with the FDA for C-port Distal Anastomosis System.
| Device ID | K053524 |
| 510k Number | K053524 |
| Device Name: | C-PORT DISTAL ANASTOMOSIS SYSTEM |
| Classification | Clip, Implantable |
| Applicant | CARDICA, INC. 900 SAGINAW DR. Redwood City, CA 94063 |
| Contact | David Casal |
| Correspondent | David Casal 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 | 2005-12-19 |
| Decision Date | 2006-11-16 |
| Summary: | summary |