📋 FDA Reference
Uresil Vascu-Flo Infusion Catheter
Summary: The Uresil Vascu-Flo Infusion Catheter is a medical device used for infusion therapy in venous stenting procedures. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K980278 ↗
Decision Date ?
November 20, 1998
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Uresil Vascu-Flo Infusion Catheter was cleared through the FDA 510k pathway on November 20, 1998. Manufactured by Uresil, it is classified as a Class 2 device under product code DQY.
What It Is
The Uresil Vascu-Flo Infusion Catheter is designed to facilitate the delivery of therapeutic agents directly into the vascular system. It is typically used in conjunction with venous stents to ensure patency and prevent thrombosis. The catheter's design allows for precise placement and controlled infusion, making it a valuable tool in vascular interventions.
FDA-Cleared Indications
- Percutaneous catheter access to the vascular system for infusion of therapeutic agents.
- Delivery of therapeutic agents through the vascular system during vascular interventions.
- Use in procedures requiring controlled intravascular infusion through a percutaneously placed catheter.
Clinical Applications
- Catheter-directed infusion during endovascular treatment of vascular disease.
- Delivery of thrombolytic or other therapeutic agents when specified by the treating physician and applicable product labeling.
- Infusion through venous access during minimally invasive vascular interventions.
- Use with imaging guidance to position the catheter in the intended vessel or treatment area.
Reported off-label uses
- Catheter-directed thrombolysis for deep vein thrombosis may be performed with infusion catheters of this type, but the specific use must be confirmed against the current device labeling and institutional policy.
- Regional infusion of other medications in selected vascular procedures may be described in clinical practice, but such use is not necessarily included in the FDA-cleared indication.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The available catheter sizes, lengths, infusion features and pressure limits should be confirmed in the current manufacturer instructions for use before the procedure.
- Use requires sterile technique, appropriate vascular access, imaging guidance and an infusion system compatible with the catheter.
- Potential complications include bleeding, hematoma, vessel injury, thrombosis, infection, catheter migration, occlusion and unintended or excessive infusion.
- MRI safety is not established from the supplied FDA record. Confirm the device's current MR Safe, MR Conditional or MR Unsafe status with the manufacturer before MRI.
- Contraindications, anticoagulation requirements and medication-specific risks depend on the planned infusion agent and the patient's vascular condition.
Procedures that use this device
Frequently Asked Questions
What is the Uresil Vascu-Flo Infusion Catheter used for?
It is used for delivering therapeutic agents during venous stenting procedures to maintain vessel patency.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in delivering therapeutic agents during venous stenting procedures to support vascular interventions.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.