CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100
FDA 510(k) clearance K101018 · decided 2010-06-25
Clearance details
- K-number
- K101018
- Device name
- CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100
- Applicant
- Cardica, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-04-13
- Decision date
- 2010-06-25
- Days to decision
- 73 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
| Record | Firm | Date |
|---|---|---|
| AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The Cardi recall (Z-2433-2018) | AESDEX | 2018-07-13 |