đź“‹ FDA Reference
angiodynamics inc percutaneous introducer and elvs procedure kit
Angiodynamics
Summary: The Angiodynamics Percutaneous Introducer and ELVS Procedure Kit is a medical device used primarily in endovenous laser therapy for varicose veins. It is typically utilized by vascular surgeons and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K040728 ↗
Decision Date
June 18, 2004
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on June 18, 2004. It is manufactured by Angiodynamics and classified as a Class 2 device under product code DYB.
What It Is
The Percutaneous Introducer and ELVS Procedure Kit is designed for use in endovenous laser therapy, a minimally invasive procedure to treat varicose veins. The kit includes components necessary for accessing the venous system and delivering laser energy to ablate the vein. This device aids in reducing symptoms and improving the appearance of varicose veins by closing off the affected veins.
Clinical Applications
Commonly used in vascular surgery and interventional radiology, this device is employed in outpatient settings or surgical centers. It is suitable for adult patients with symptomatic varicose veins, often due to chronic venous insufficiency. The procedure is typically performed under local anesthesia, making it accessible for a wide range of patients.
Indications for Use
The FDA indications suggest this device is for patients with varicose veins requiring endovenous laser treatment. It is particularly beneficial for those experiencing pain, swelling, or other symptoms related to venous insufficiency.
Practical Considerations
The kit is available in various sizes to accommodate different patient anatomies and procedural needs. Compatibility with specific laser systems should be verified prior to use. Clinicians should be trained in endovenous techniques to ensure optimal outcomes.
Frequently Asked Questions
What is the Percutaneous Introducer and ELVS Procedure Kit used for?
It is used for endovenous laser therapy to treat varicose veins.
What specialties typically use this device?
Vascular surgeons and interventional radiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for the treatment of varicose veins through endovenous laser therapy.
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.