FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES
K Number: K073304
·
Decision Dec 20, 2007
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
175
Applicant Total
15
Review Days
27
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Basic Information
- Device Name
- CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES
- K Number
- K073304
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardica, Inc.
- Date Received
- November 23, 2007
- Decision Date
- December 20, 2007
- Product Code
- FZP
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FZP | Clip, Implantable | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Cardica, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K161137 | Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload | Jul 20, 2016 | Substantially Equivalent |
| K151081 | MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge | Jan 15, 2016 | Substantially Equivalent |
| K140118 | MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE | Feb 25, 2014 | Substantially Equivalent |
| K140170 | MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE | Feb 19, 2014 | Substantially Equivalent |
| K132581 | MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE | Jan 7, 2014 | Substantially Equivalent |
| K101018 | CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100 | Jun 25, 2010 | Substantially Equivalent |
| K091017 | CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001 | Apr 29, 2009 | Substantially Equivalent |
| K090872 | MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM | Apr 21, 2009 | Substantially Equivalent |
| K081225 | CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM | Sep 5, 2008 | Substantially Equivalent |
| K073123 | CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150 | Dec 6, 2007 | Substantially Equivalent |