The following data is part of a premarket notification filed by Cardica, Inc. with the FDA for Cardica Pas-port Proximal Anastomosis System.
| Device ID | K081225 |
| 510k Number | K081225 |
| Device Name: | CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM |
| Classification | Clip, Implantable |
| Applicant | CARDICA, INC. 900 SAGINAW DR. Redwood City, CA 94063 |
| Contact | Iskra Mrakovic |
| Correspondent | Iskra Mrakovic 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 | 2008-04-30 |
| Decision Date | 2008-09-05 |
| Summary: | summary |