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ultra -thin sds balloon dilatation catheter
Boston Scientific
Summary: The ultra-thin SDS balloon dilatation catheter is a medical device used primarily for venous stent procedures. It is typically utilized by interventional radiologists and cardiologists to dilate narrowed or obstructed veins.
FDA Clearance Information
Pathway
510K
Number
K011889 ↗
Decision Date
December 21, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ultra-thin SDS balloon dilatation catheter was cleared through the FDA 510k pathway on December 21, 2001, by Boston Scientific. It is classified as a Class 2 device under product code DQY.
What It Is
The ultra-thin SDS balloon dilatation catheter is a specialized catheter designed for dilating narrowed or obstructed venous pathways. It features a balloon that can be inflated to widen the vessel, facilitating improved blood flow. This device is particularly useful in procedures involving venous stents, where precise dilation is required to ensure proper stent placement and function.
Clinical Applications
This catheter is commonly used in interventional radiology and cardiology settings for procedures involving venous stents. It is particularly beneficial in treating patients with venous obstructions or stenosis, often seen in conditions such as deep vein thrombosis or post-thrombotic syndrome. The catheter's design allows for precise control and effective dilation in complex vascular anatomies.
Indications for Use
The FDA indications for this device include use in procedures that require dilation of venous pathways, particularly when placing or adjusting stents. It is intended for patients with narrowed or obstructed veins that impede normal blood flow.
Practical Considerations
The ultra-thin design of the catheter allows for navigation through narrow or tortuous vessels. It is compatible with a range of stent sizes and can be used with standard guidewires. Clinicians should ensure appropriate balloon sizing relative to the target vessel to optimize outcomes.
Frequently Asked Questions
What is the ultra-thin SDS balloon dilatation catheter used for?
It is used for dilating narrowed or obstructed venous pathways, often in conjunction with venous stent placement.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring dilation of venous pathways, especially when placing or adjusting stents in narrowed or obstructed veins.
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.