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5 5 f worley advanced lvi lateral vein introducer
Merit Medical Systems
Summary: The 5 5 F Worley Advanced LVI Lateral Vein Introducer is a medical device used for the introduction of catheters into the lateral veins. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K152116 ↗
Decision Date
August 27, 2015
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The 5 5 F Worley Advanced LVI Lateral Vein Introducer, manufactured by Merit Medical Systems, received FDA clearance via the 510(k) pathway on August 27, 2015. It is classified as a Class 2 device under product code DYB.
What It Is
The 5 5 F Worley Advanced LVI Lateral Vein Introducer is a specialized tool designed to facilitate the insertion of catheters into lateral veins, particularly in cardiac procedures. It features a flexible design to navigate the vascular system efficiently. This device is crucial in procedures requiring precise catheter placement, offering enhanced control and access to targeted vein sites.
Clinical Applications
This device is commonly used in interventional cardiology and radiology, especially during procedures like cardiac resynchronization therapy (CRT) where lateral vein access is necessary. It is utilized in hospital settings, particularly in catheterization labs, to aid in the placement of pacemaker leads or other cardiac devices. The device is suitable for adult patients requiring such interventions.
Indications for Use
The FDA-cleared indications for this device involve its use in introducing catheters into lateral veins, which is essential in procedures like CRT. It is intended for patients who need precise catheter placement in the cardiac veins.
Practical Considerations
The device typically comes in a standard 5 5 F size, compatible with a range of catheter types. Clinicians should be aware of the device's compatibility with existing catheter systems and ensure proper technique to avoid vascular complications.
Frequently Asked Questions
What is the 5 5 F Worley Advanced LVI Lateral Vein Introducer used for?
It is used for the introduction of catheters into lateral veins, particularly in cardiac procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for introducing catheters into lateral veins, particularly in cardiac procedures requiring precise placement.
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.