📋 FDA Reference
Ultra -Thin Sds Balloon Dilatation Catheter
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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 ?
510(k)
Number ?
K011889 ↗
Decision Date ?
December 21, 2001
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Use as a percutaneous catheter for endovascular vascular procedures, consistent with product code DQY and 21 CFR 870.1250.
- The supplied FDA summary does not state a more specific vessel, disease, or procedure indication.
Clinical Applications
- Balloon dilation of a narrowed vascular segment during a percutaneous endovascular procedure, when consistent with the device labeling.
- Dilation of a venous segment during venous stent placement or adjustment, when included in the applicable product labeling.
- Use in interventional procedures requiring catheter-based vascular dilation through a guidewire.
Practical Considerations
- Select balloon diameter and length according to the target vessel, lesion, and applicable manufacturer instructions for use; avoid oversizing.
- Confirm guidewire, introducer, and catheter compatibility before the procedure. The supplied record does not list the available balloon sizes or shaft specifications.
- Use fluoroscopic or other appropriate intravascular imaging guidance, with careful inflation and deflation to reduce the risk of vessel injury.
- MRI safety, including MR Safe, MR Conditional, or MR Unsafe status, cannot be determined from the supplied FDA record; check the current labeling before MRI.
- Review contraindications, warnings, and preparation requirements in the current manufacturer instructions for use. Potential procedural risks include bleeding, thrombosis, embolization, dissection, perforation, restenosis, and contrast-related complications.
Procedures that use this device
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.