C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM
FDA 510(k) clearance K070548 · decided 2007-03-29
Clearance details
- K-number
- K070548
- Device name
- C-PORT FLEXA DISTAL ANASTOMOSIS SYSTEM
- Applicant
- Cardica, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-02-26
- Decision date
- 2007-03-29
- Days to decision
- 31 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 Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-00015 recall (Z-2434-2018) | AESDEX | 2018-07-13 |