đź“‹ FDA Reference
rx viatrac 14 peripheral dilatation catheter otw viatrac 18 peripheral dilatation catheter rx herculink 14 biliary stn
Vascular Intervention
Summary: The RX Viatrac and Herculink catheters are used for peripheral and biliary dilatation procedures, primarily by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K011464 ↗
Decision Date
June 13, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The RX Viatrac 14 and 18 Peripheral Dilatation Catheters and RX Herculink 14 Biliary Stent received FDA 510k clearance on June 13, 2001. Manufactured by Vascular Intervention, these devices are classified as Class 2 under product code DQY.
What It Is
The RX Viatrac catheters are designed for peripheral vascular dilatation, facilitating the opening of narrowed or blocked blood vessels. The RX Herculink stent is used for biliary applications, providing structural support to maintain ductal patency. These devices are crucial in minimally invasive procedures to restore blood flow or bile flow, using over-the-wire (OTW) technology for precise placement.
Clinical Applications
These devices are commonly used in interventional radiology and vascular surgery settings. The RX Viatrac catheters are employed in procedures to treat peripheral artery disease, especially in the lower extremities. The RX Herculink stent is used in biliary interventions to alleviate obstructions caused by conditions such as strictures or tumors. Patients benefiting from these devices often have conditions that impair normal blood or bile flow.
Indications for Use
The FDA-cleared indications for these devices include the treatment of peripheral arterial disease and biliary obstructions. They are intended for patients with narrowed or blocked vessels that require mechanical dilation or stenting to restore function.
Practical Considerations
The RX Viatrac catheters come in various sizes to accommodate different vessel diameters and lengths, ensuring compatibility with a range of anatomical variations. The RX Herculink stent is designed for easy deployment and precise placement. Clinicians should be familiar with OTW techniques and ensure compatibility with existing guidewires and sheaths.
Frequently Asked Questions
What is RX Viatrac & Herculink used for?
These devices are used for dilating peripheral vessels and stenting biliary ducts to treat obstructions.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use these devices.
What are the FDA-cleared indications?
They are indicated for peripheral vascular dilatation and biliary stenting to treat obstructions.
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.