The following data is part of a premarket notification filed by Cardica, Inc. with the FDA for C-port Flexa Distal Anastomosis System.
| Device ID | K070548 |
| 510k Number | K070548 |
| Device Name: | C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM |
| Classification | Clip, Implantable |
| Applicant | CARDICA, INC. 900 SAGINAW DR. Redwood City, CA 94063 |
| Contact | Tiffini Lalude |
| Correspondent | Tiffini Lalude 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 | 2007-02-26 |
| Decision Date | 2007-03-29 |
| Summary: | summary |