đź“‹ FDA Reference
gore tri-lumen catheter
W. L. Gore And Associates
Summary: The Gore Tri-Lumen Catheter is a medical device used primarily in vascular procedures to facilitate venous access and stenting. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K180919 ↗
Decision Date
October 5, 2018
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Gore Tri-Lumen Catheter was cleared through the FDA 510(k) pathway on October 5, 2018. Manufactured by W. L. Gore And Associates, it is classified as a Class II device under product code DQY.
What It Is
The Gore Tri-Lumen Catheter is a specialized catheter designed for use in vascular procedures, particularly those involving venous stenting. It features three lumens, allowing for simultaneous administration of fluids, medications, and the placement of guidewires or other instruments. This design enhances procedural efficiency and safety, making it a valuable tool in complex vascular interventions.
Clinical Applications
This device is commonly used in procedures requiring venous access, such as the placement of venous stents in patients with venous insufficiency or obstruction. It is frequently utilized in interventional radiology and vascular surgery settings, particularly in hospitals and specialized vascular centers. The catheter is suitable for adult patients who require complex vascular interventions.
Indications for Use
The FDA indications for the Gore Tri-Lumen Catheter include its use in facilitating venous access and stenting procedures. It is intended for patients who need interventions to address venous blockages or insufficiencies.
Practical Considerations
The Gore Tri-Lumen Catheter comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard vascular access equipment and requires careful handling to ensure proper placement and function. Clinicians should be trained in its use to maximize its benefits and minimize complications.
Frequently Asked Questions
What is the Gore Tri-Lumen Catheter used for?
The Gore Tri-Lumen Catheter is used for facilitating venous access and stenting in vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in venous access and stenting procedures for patients with venous insufficiency 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.