MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT— 510(k) K033473
Substantially EquivalentHorizon Medical Products, Inc.
FDA 510(k) clearance K033473 for MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT, Substantially Equivalent on 2003-11-18. Applicant: Horizon Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Horizon Medical Products, Inc.
- Product code
- Code LJT
- Device class
- Class 2
- Regulation
- 21 CFR 880.5965
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Manchester, GA, US
Recent devices under product code LJT
view all- K260916 — FLEXI-PORT Power Injectable Implantable Port
- K252478 — Vaccess CT Low-Profile Power-Injectable Implantable Port +2 more
- K251253 — PowerPort isp Implantable Port +3 more
- K242328 — PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports
- K232737 — PowerPort ClearVUE Slim ECG Enabled Implantable Port +3 more
More clearances from Horizon Medical Products, Inc.
view allAdverse events under product code LJT
product code LJT- Death
- 234
- Injury
- 6,468
- Malfunction
- 5,326
- Other
- 2
- Total
- 12,030
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K033473
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033473.
Data sourced from openFDA. This site is unofficial and independent of the FDA.