The following data is part of a premarket notification filed by Cardica, Inc. with the FDA for Dextera Microcutter 5/80 Blue Reload, Dextera Microcutter 5/80 Blue Curved Tip Reload.
| Device ID | K161137 |
| 510k Number | K161137 |
| Device Name: | Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload |
| Classification | Staple, Implantable |
| Applicant | CARDICA, INC. 900 Saginaw Dr Redwood City, CA 94063 |
| Contact | Greg Watson |
| Correspondent | Greg Watson CARDICA, INC. 900 Saginaw Dr Redwood City, CA 94063 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-22 |
| Decision Date | 2016-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 11814900003216 | K161137 | 000 |
| 11814900003209 | K161137 | 000 |