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edslab catheter cover
American Edwards Laboratories
Summary: The edslab catheter cover is a medical device used to protect venous stents during procedures. It is primarily used by interventional radiologists and cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K813514 ↗
Decision Date
December 29, 1981
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The edslab catheter cover was cleared through the FDA 510(k) pathway on December 29, 1981. It is manufactured by American Edwards Laboratories and classified as a Class 2 device under product code DQY.
What It Is
The edslab catheter cover is designed to provide a protective barrier for venous stents during insertion and manipulation. It helps reduce the risk of contamination and mechanical damage to the stent. The cover is typically made from biocompatible materials that ensure patient safety during use.
Clinical Applications
This device is commonly used in procedures involving the placement or adjustment of venous stents, particularly in patients with venous insufficiency or obstruction. It is utilized in interventional radiology and cardiology departments, often in hospital catheterization labs. The device is suitable for adult patients requiring venous stenting.
Indications for Use
The edslab catheter cover is indicated for use in procedures involving venous stents, providing a protective barrier during insertion. It is intended for patients who require venous stenting, such as those with venous blockages or insufficiencies.
Practical Considerations
The edslab catheter cover comes in various sizes to accommodate different stent dimensions. It is compatible with standard catheterization equipment. Clinicians should ensure proper sizing and secure placement to maintain sterility and effectiveness during procedures.
Frequently Asked Questions
What is edslab catheter cover used for?
The edslab catheter cover is used to protect venous stents during insertion and manipulation in medical procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use the edslab catheter cover in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in protecting venous stents during procedures, particularly for patients with venous insufficiencies or blockages.
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.