VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100
FDA 510(k) clearance K061373 · decided 2006-08-01
Clearance details
- K-number
- K061373
- Device name
- VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100
- Applicant
- Vnus Medical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-05-17
- Decision date
- 2006-08-01
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VNUS 7F ClosureFAST Catheter, Order #: CF7-7-60 (60 cm working length), Manufactured by VN recall (Z-0542-2008) | VNUS Medical Technologies Inc | 2008-01-24 |
| VNUS ClosureFAST catheters, Model Number: CL7-7-100, VNUS Medical Technologies, Inc., San recall (Z-0132-2008) | VNUS Medical Technologies Inc | 2007-12-15 |