The following data is part of a premarket notification filed by Cardica, Inc. with the FDA for Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple Cartridge.
| Device ID | K132581 |
| 510k Number | K132581 |
| Device Name: | MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE |
| Classification | Staple, Implantable |
| Applicant | CARDICA, INC. 900 SAGINAW DR. Redwood City, CA 94063 |
| Contact | Frederick Bauer |
| Correspondent | Frederick Bauer 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 | 2013-08-16 |
| Decision Date | 2014-01-07 |
| Summary: | summary |