VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET
FDA 510(k) clearance K062414 · decided 2007-02-01
Clearance details
- K-number
- K062414
- Device name
- VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET
- Applicant
- Rita Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-08-17
- Decision date
- 2007-02-01
- Days to decision
- 168 days
- Clearance type
- Traditional
- Product code
- LJT
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Manchester, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 8F Smart Port CT, Catalog number: CT80STPD and CT80STPD-NF; AngioDynamics, INC. The Smart recall (Z-0056-2012) | Angiodynamics, INC | 2011-10-13 |