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gore r tri-lobe balloon catheter
W.L. Gore & Associates
Summary: The Gore R Tri-Lobe Balloon Catheter is a medical device used primarily in venous stenting procedures. It is typically utilized by interventional radiologists and vascular surgeons to assist in the placement and expansion of venous stents.
FDA Clearance Information
Pathway
510K
Number
K250410 ↗
Decision Date
June 2, 2025
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Gore R Tri-Lobe Balloon Catheter was cleared through the FDA 510(k) pathway on June 2, 2025. Manufactured by W.L. Gore & Associates, it is classified as a Class 2 medical device.
What It Is
The Gore R Tri-Lobe Balloon Catheter is a specialized catheter designed to assist in the deployment and expansion of stents within venous structures. It features a tri-lobe balloon design that allows for precise control and expansion of stents, ensuring optimal placement and patency. This device is particularly useful in procedures requiring precise manipulation within the venous system.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly for patients with venous obstructions or conditions requiring stent placement. It is suitable for use in both hospital and outpatient settings, and is often employed in procedures involving the iliac veins, femoral veins, or other large venous structures. The catheter's design facilitates its use in complex cases where accurate stent deployment is critical.
Indications for Use
The FDA-cleared indications for the Gore R Tri-Lobe Balloon Catheter include its use in procedures requiring venous stent placement. It is intended for patients with venous stenosis or obstruction, where stent placement is necessary to restore proper blood flow.
Practical Considerations
The Gore R Tri-Lobe Balloon Catheter is available in various sizes to accommodate different venous anatomies and stent sizes. It is compatible with standard guidewires and stent systems, making it versatile for use in a range of procedures. Clinicians should be familiar with balloon inflation techniques to ensure optimal stent expansion and positioning.
Frequently Asked Questions
What is the Gore R Tri-Lobe Balloon Catheter used for?
It is used for the deployment and expansion of stents in venous structures, aiding in procedures that address venous obstructions.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in venous stenting procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous stent placement, particularly in cases of venous stenosis or obstruction.
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.