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boston scientific ultra-soft sv balloon dilatation catheter
Boston Scientific Scimed
Summary: The Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter is a medical device used for dilating venous pathways, commonly utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K021735 ↗
Decision Date
August 8, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510k pathway on August 8, 2002, by Boston Scientific Scimed. It is classified as a Class 2 device under product code DQY.
What It Is
The Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter is designed to facilitate the expansion of narrowed venous segments. It consists of a flexible catheter with an inflatable balloon at its tip, which can be precisely positioned and inflated to dilate the vessel. This device is particularly useful in procedures requiring gentle and controlled dilation to minimize trauma to the vessel walls.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery settings to treat venous stenosis, particularly in patients with conditions like chronic venous insufficiency or those requiring venous stenting. It is often employed in hospital settings where imaging guidance is available, and it is suitable for adult patients experiencing venous narrowing.
Indications for Use
The device is indicated for use in patients who require dilation of narrowed venous pathways. This includes individuals with venous stenosis that may benefit from improved blood flow through dilated vessels.
Practical Considerations
The catheter is available in various sizes to accommodate different vessel diameters and is compatible with standard imaging techniques for precise placement. Clinicians should ensure proper sizing and inflation techniques to optimize outcomes and minimize complications.
Frequently Asked Questions
What is the Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter used for?
It is used for dilating narrowed venous pathways to improve blood flow.
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 dilation of narrowed venous pathways in patients with venous stenosis.
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.