The following data is part of a premarket notification filed by Cardica, Inc. with the FDA for Cardica C-port Flex-a Distal Anastomosis System, Model Fg-000150.
| Device ID | K073123 |
| 510k Number | K073123 |
| Device Name: | CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150 |
| 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 | 2007-11-06 |
| Decision Date | 2007-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 11814900001502 | K073123 | 000 |