The following data is part of a premarket notification filed by Cardica, Inc. with the FDA for Cardica C-port Xa Plus Distal Anastomosis System, Model Fg-000100.
| Device ID | K101018 |
| 510k Number | K101018 |
| Device Name: | CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100 |
| Classification | Clip, Implantable |
| Applicant | CARDICA, INC. 900 SAGINAW DR. Redwood City, CA 94063 |
| Contact | Matthew E Chroust |
| Correspondent | Matthew E Chroust 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 | 2010-04-13 |
| Decision Date | 2010-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 11814900001007 | K101018 | 000 |