Cardica, Inc.
FDA Regulatory Profile
Cardica, Inc. appears in FDA public data with 2 recalls, 15 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0483-2016, Class II) was initiated on November 6, 2015. Its most recent 510(k) clearance was granted on July 20, 2016.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 15
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0483-2016 | Class II | MicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321; The MicroCutter XCHANGE | November 6, 2015 |
| Z-0482-2016 | Class II | MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and Mic | November 6, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K161137 | Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload | July 20, 2016 |
| K151081 | MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White | January 15, 2016 |
| K140118 | MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE | February 25, 2014 |
| K140170 | MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE | February 19, 2014 |
| K132581 | MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE | January 7, 2014 |
| K101018 | CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100 | June 25, 2010 |
| K091017 | CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001 | April 29, 2009 |
| K090872 | MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM | April 21, 2009 |
| K081225 | CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM | September 5, 2008 |
| K073304 | CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES | December 20, 2007 |
| K073123 | CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150 | December 6, 2007 |
| K070548 | C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM | March 29, 2007 |
| K063644 | CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM | January 11, 2007 |
| K053524 | C-PORT DISTAL ANASTOMOSIS SYSTEM | November 16, 2006 |
| K040832 | C-PORT ANASTOMOSIS SYSTEM (DEPLOYMENT SYSTEM, CLIP, ACCESSORIES), MODEL FG-000050 | November 10, 2005 |