Cardica, Inc.
Medical device manufacturer in Redwood City, CA.
15510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K161137 | Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadGDW · Traditional | 07/20/2016SE |
| K151081 | MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter…GDW · Traditional | 01/15/2016SE |
| K140118 | Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue CartridgeGDW · Special | 02/25/2014SE |
| K140170 | Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White CartridgeGDW · Special | 02/19/2014SE |
| K132581 | Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple…GDW · Traditional | 01/07/2014SE |
| K101018 | Cardica C-Port Xa Plus Distal Anastomosis System, Model FG-000100FZP · Special | 06/25/2010SE |
| K091017 | Cardica Pas-Port Proximal Anastomosis System, Model FG-000001FZP · Special | 04/29/2009SE |
| K090872 | Modification to Cardica C-Port Xa Distal Anastomosis SystemFZP · Special | 04/21/2009SE |
| K081225 | Cardica Pas-Port Proximal Anastomosis SystemFZP · Traditional | 09/05/2008SE |
| K073304 | Cardica C-Port X-Change Anastomosis System and Handle and Xa X-Change SubassembliesFZP · Special | 12/20/2007SE |
| K073123 | Cardica C-Port Flex-A Distal Anastomosis System, Model FG-000150FZP · Special | 12/06/2007SE |
| K070548 | C-Port Flexa Distal Anastomosis SystemFZP · Special | 03/29/2007SE |
| K063644 | Cardica C-Port Xa Distal Anastomosis SystemFZP · Special | 01/11/2007SE |
| K053524 | C-Port Distal Anastomosis SystemFZP · Traditional | 11/16/2006SE |
| K040832 | C-Port Anastomosis System (Deployment System, Clip, Accessories), Model FG-000050FZP · Traditional | 11/10/2005SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0483-2016 Class II | MicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321; The…Cardica, Inc. has received reports that use of the Blue Cartridges with the MicroCutter XCHANGE 30 Stapler… | 11/06/2015Terminated |
| Z-0482-2016 Class II | MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue…Cardica, Inc. has received reports that use of the Blue Cartridges with the MicroCutter XCHANGE 30 Stapler… | 11/06/2015Terminated |