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edslab r occlusion balloon catheter
American Edwards Laboratories
Summary: The edslab r occlusion balloon catheter is a medical device used to temporarily occlude blood vessels. It is primarily utilized by interventional radiologists and vascular surgeons in procedures involving venous stents.
FDA Clearance Information
Pathway
510K
Number
K873485 ↗
Decision Date
December 3, 1987
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The edslab r occlusion balloon catheter was cleared through the FDA 510(k) pathway on December 3, 1987. Manufactured by American Edwards Laboratories, it is classified as a Class 2 device under product code DQY.
What It Is
The edslab r occlusion balloon catheter is designed to temporarily block blood flow in a vessel. It consists of a flexible catheter with an inflatable balloon at its tip. When the balloon is inflated, it occludes the vessel, allowing clinicians to perform procedures such as stent placement or to control bleeding. This device is particularly useful in managing venous conditions where temporary occlusion is necessary.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures requiring temporary vessel occlusion, such as during the placement of venous stents or to control hemorrhage. The device is suitable for adult patients with vascular conditions that necessitate temporary blood flow interruption. It is often used in hospital settings, particularly in catheterization labs or operating rooms.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures where temporary occlusion of a blood vessel is required. This includes patients undergoing venous stent placement or those needing temporary control of blood flow during surgical interventions.
Practical Considerations
The catheter comes in various sizes to accommodate different vessel diameters, ensuring compatibility with a range of patient anatomies. Clinicians should be familiar with the inflation technique and pressure limits to prevent vessel damage. It is crucial to verify compatibility with other devices used during the procedure.
Frequently Asked Questions
What is edslab r occlusion balloon catheter used for?
It is used to temporarily occlude blood vessels during procedures such as venous stent placement or to control bleeding.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring temporary occlusion of blood vessels, such as during venous stent placement or surgical interventions.
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.