VORTEX ACCESS SYSTEM
FDA 510(k) clearance K010189 · decided 2001-02-12
Clearance details
- K-number
- K010189
- Device name
- VORTEX ACCESS SYSTEM
- Applicant
- Horizon Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-01-22
- Decision date
- 2001-02-12
- Days to decision
- 21 days
- Clearance type
- Special
- 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 |
|---|---|---|
| Vortex VX Port, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816 recall (Z-0402-2011) | Angiodynamics, INC | 2010-11-17 |
| Vortex VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex Free recall (Z-0149-2008) | Rita Medical Systems, Inc. | 2007-12-28 |