Company ยท US
Cardica, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2016. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 20, 2016 | K161137 | Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload Cardica, Inc. | GDW |
| Jan 15, 2016 | K151081 | MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge Cardica, Inc. | GDW |
| Feb 25, 2014 | K140118 | MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE Cardica, Inc. | GDW |
| Feb 19, 2014 | K140170 | MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE Cardica, Inc. | GDW |
| Jan 7, 2014 | K132581 | MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE Cardica, Inc. | GDW |
| Jun 25, 2010 | K101018 | CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100 Cardica, Inc. | FZP |
| Apr 29, 2009 | K091017 | CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001 Cardica, Inc. | FZP |
| Apr 21, 2009 | K090872 | MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM Cardica, Inc. | FZP |
| Sep 5, 2008 | K081225 | CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Cardica, Inc. | FZP |
| Dec 20, 2007 | K073304 | CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES Cardica, Inc. | FZP |
| Dec 6, 2007 | K073123 | CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150 Cardica, Inc. | FZP |
| Mar 29, 2007 | K070548 | C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM Cardica, Inc. | FZP |
| Jan 11, 2007 | K063644 | CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM Cardica, Inc. | FZP |
| Nov 16, 2006 | K053524 | C-PORT DISTAL ANASTOMOSIS SYSTEM Cardica, Inc. | FZP |
| Nov 10, 2005 | K040832 | C-PORT ANASTOMOSIS SYSTEM (DEPLOYMENT SYSTEM, CLIP, ACCESSORIES), MODEL FG-000050 Cardica, Inc. | FZP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 24, 2015 | Cardica, Inc. MicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321;
The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel s Terminated |
GDW | K140118 K140170 |
| Dec 24, 2015 | Cardica, Inc. MicroCutter Xchange 30 Blue Cartridge, FG-025320;
The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges ar Terminated |
GDW | K132581 K140118 +1 |