📋 FDA Reference
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 ?
510(k)
Number ?
K021735 ↗
Decision Date ?
August 8, 2002
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Dilation of stenotic peripheral blood vessels.
- Percutaneous transluminal angioplasty of narrowed vascular segments.
- Use in adults when balloon dilation is clinically indicated and the selected catheter size is appropriate for the target vessel.
Clinical Applications
- Balloon dilation of a narrowed peripheral venous segment.
- Percutaneous treatment of vascular stenosis before or during placement of a vascular stent.
- Image-guided dilation of a stenotic vessel in an interventional radiology or vascular surgery procedure.
Reported off-label uses
- Dilation of selected dialysis-access or central venous stenoses when the device size and anatomy are appropriate.
- Balloon dilation of venous lesions associated with chronic venous obstruction, when performed outside the specific cleared labeling.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The catheter must be selected based on the target vessel diameter, lesion length, access route, and required balloon dimensions.
- Placement and inflation are performed over suitable guidewire access with fluoroscopic or other appropriate imaging guidance.
- Inflation pressure, duration, and number of inflations should follow the device labeling and the treating clinician's judgment; overinflation can injure the vessel.
- Check compatibility with the guidewire, introducer sheath, contrast medium, and other equipment before use.
- MRI safety and conditional-use information should be confirmed in the current manufacturer labeling; do not assume the device is MRI safe based only on its name.
Procedures that use this device
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.