đź“‹ FDA Reference
radiopaque 7 frx 12-polyurethane multi
Arrow Intl.
Summary: The radiopaque 7 Frx 12-polyurethane multi is a venous stent used primarily in vascular procedures to maintain open blood flow in veins. It is typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K840336 ↗
Decision Date
February 17, 1984
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on February 17, 1984, by Arrow Intl. It is classified as a Class 2 device under product code DQY.
What It Is
This device is a radiopaque polyurethane stent designed for use in venous applications. Its radiopaque nature allows for easy visualization under imaging, facilitating precise placement. The 7 Frx 12 size indicates its diameter and length, suitable for various venous interventions to ensure patency and support blood flow.
Clinical Applications
Commonly used in procedures requiring venous stenting, this device is employed in settings like interventional radiology suites and operating rooms. It is particularly useful in treating venous obstructions or stenosis, often seen in patients with conditions such as deep vein thrombosis or post-thrombotic syndrome. The device is suitable for adult patients requiring long-term venous support.
Indications for Use
The device is indicated for use in patients with venous blockages or narrowing that require stenting to maintain open blood flow. It is particularly beneficial for those with chronic venous insufficiency or similar vascular conditions.
Practical Considerations
The 7 Frx 12 size is a common choice for medium to large veins. Compatibility with standard vascular access kits is typical, and clinicians should ensure proper imaging techniques for optimal placement. Familiarity with stent deployment techniques is essential for effective use.
Frequently Asked Questions
What is the radiopaque 7 Frx 12-polyurethane multi used for?
It is used to maintain open blood flow in veins, particularly in cases of venous obstruction or narrowing.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in treating venous blockages or stenosis to support blood flow.
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.