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Cardica, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0483-2016Class IIMicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321; The MicroCutter XCHANGE November 6, 2015
Z-0482-2016Class IIMicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicNovember 6, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadJuly 20, 2016
K151081MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White January 15, 2016
K140118MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGEFebruary 25, 2014
K140170MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGEFebruary 19, 2014
K132581MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGEJanuary 7, 2014
K101018CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100June 25, 2010
K091017CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001April 29, 2009
K090872MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEMApril 21, 2009
K081225CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEMSeptember 5, 2008
K073304CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIESDecember 20, 2007
K073123CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150December 6, 2007
K070548C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEMMarch 29, 2007
K063644CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEMJanuary 11, 2007
K053524C-PORT DISTAL ANASTOMOSIS SYSTEMNovember 16, 2006
K040832C-PORT ANASTOMOSIS SYSTEM (DEPLOYMENT SYSTEM, CLIP, ACCESSORIES), MODEL FG-000050November 10, 2005