The following data is part of a premarket notification filed by Cardica, Inc. with the FDA for Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue Cartridge, Microcutter Xchange 30 White Cartridge.
| Device ID | K151081 |
| 510k Number | K151081 |
| Device Name: | MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge |
| Classification | Staple, Implantable |
| Applicant | Cardica, Inc. 900 Saginaw Drive Redwood City, CA 94063 |
| Contact | Vee Arya |
| Correspondent | Cindy Domecus DOMECUS CONSULTING SERVICES, LLC 1171 BARROILHET DRIVE Hillsborough, CA 94010 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-22 |
| Decision Date | 2016-01-15 |
| Summary: | summary |