đź“‹ FDA Reference
sterling monorail pta balloon dilatation catheter model h74939031-xxxxxx
Boston Scientific
Summary: The Sterling Monorail PTA Balloon Dilatation Catheter is a medical device used primarily for percutaneous transluminal angioplasty (PTA) procedures. It is utilized by interventional radiologists and vascular surgeons to treat vascular stenosis.
FDA Clearance Information
Pathway
510K
Number
K053118 ↗
Decision Date
December 16, 2005
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Sterling Monorail PTA Balloon Dilatation Catheter, manufactured by Boston Scientific, received FDA clearance through the 510(k) pathway on December 16, 2005. It is classified as a Class 2 device under product code DQY.
What It Is
The Sterling Monorail PTA Balloon Dilatation Catheter is a specialized catheter designed for use in percutaneous transluminal angioplasty (PTA) procedures. It features a balloon at its tip that can be inflated to dilate narrowed blood vessels, improving blood flow. The monorail design allows for easier navigation and placement within the vascular system, providing clinicians with enhanced control during procedures.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery to treat peripheral artery disease (PAD) by dilating stenotic or occluded blood vessels. It is particularly useful in procedures involving the femoral, popliteal, and tibial arteries. The catheter is suitable for use in both hospital and outpatient settings, catering to adult patients with atherosclerotic vascular disease.
Indications for Use
The FDA indications for the Sterling Monorail PTA Balloon Dilatation Catheter include its use in dilating stenotic segments of blood vessels, particularly in the peripheral vasculature. It is intended for patients with conditions such as peripheral artery disease (PAD) that result in narrowed or blocked arteries.
Practical Considerations
The Sterling Monorail PTA Balloon Catheter is available in various sizes to accommodate different vessel diameters and lesion lengths. It is compatible with standard guidewires and introducer sheaths. Clinicians should be familiar with the monorail technique for optimal device handling and placement.
Frequently Asked Questions
What is the Sterling Monorail PTA Balloon Dilatation Catheter used for?
It is used for dilating narrowed or blocked blood vessels in peripheral artery disease (PAD) during percutaneous transluminal angioplasty (PTA) procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for dilating stenotic segments of peripheral blood vessels, particularly in patients with peripheral artery disease (PAD).
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.