MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT
FDA 510(k) clearance K033473 · decided 2003-11-18
Clearance details
- K-number
- K033473
- Device name
- MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT
- Applicant
- Horizon Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-11-03
- Decision date
- 2003-11-18
- Days to decision
- 15 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 MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and recall (Z-0132-2023) | Angiodynamics, Inc. | 2022-10-25 |
| Vortex MP Port Single Titanium Port with Attached (5Fr) Silicone Catheter, AngioDynamics, recall (Z-3071-2011) | Angiodynamics, INC | 2011-08-24 |