Smartport Ct Vortex +1 more model
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K081472 FDA 510(k)
- FDA Product Code
- LJT FDA 510(k)
- Models / Variants
- Smartport Ct Vortex FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5965 FDA 510(k)
- Regulation Number
- 880.5965 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a subcutaneous implanted vascular access port system, specifically the SmartPort CT Vortex series, designed for intravascular access. It is a port and catheter system intended for use in general hospital settings.
The device is supplied as a single-use, implanted system and has received FDA 510(k) clearance (K081472) as substantially equivalent to a predicate device. It is classified as a Class II medical device under regulation number 880.5965 with product code LJT.
Frequently asked questions
What is the SmartPort CT Vortex used for?
The SmartPort CT Vortex is an implanted vascular access port system designed for intravascular access, providing a subcutaneous port and catheter for repeated access to the bloodstream in general hospital settings such as for chemotherapy, transfusions, or long-term medication delivery.
Is the SmartPort CT Vortex supplied sterile and for single use only?
Yes, the SmartPort CT Vortex is supplied as a single-use, implanted system, meaning it is intended for one-time implantation and is provided in a sterile condition to prevent infection during the procedure.
What regulatory clearance does the SmartPort CT Vortex have?
The SmartPort CT Vortex has received FDA 510(k) clearance under submission number K081472, determined to be substantially equivalent to a predicate device, and is classified as a Class II medical device under regulation 880.5965 with product code LJT.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Vortex Ports - Angiodynamics, SmartPort Power-Injectable Port Family | AngioDynamics, Smartport Ct Vortex; Lp Titanium, Single Plastic, Single Titanium ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081472 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Angiodynamics, Inc.
Sources (1)
- FDA 510(k) K081472 24 fields · synced Oct 1, 2026