CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES
FDA 510(k) clearance K073304 · decided 2007-12-20
Clearance details
- K-number
- K073304
- Device name
- CARDICA C-PORT X-CHANGE ANASTOMOSIS SYSTEM AND HANDLE AND XA X-CHANGE SUBASSEMBLIES
- Applicant
- Cardica, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-11-23
- Decision date
- 2007-12-20
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- FZP
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.