The following data is part of a premarket notification filed by Cardica, Inc. with the FDA for Cardica C-port X-change Anastomosis System And Handle And Xa X-change Subassemblies.
| Device ID | K073304 |
| 510k Number | K073304 |
| Device Name: | CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-23 |
| Decision Date | 2007-12-20 |
| Summary: | summary |