VORTEX MP
FDA 510(k) clearance K032754 · decided 2003-09-12
Clearance details
- K-number
- K032754
- Device name
- VORTEX MP
- Applicant
- Horizon Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-05
- Decision date
- 2003-09-12
- Days to decision
- 7 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 Single Titanium Port with Attachable (5Fr) Silicone Catheter, AngioDynamics recall (Z-3072-2011) | Angiodynamics, INC | 2011-08-24 |