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sterling otw pta balloon dilatation catheter model h74939032-xxxxxx
Boston Scientific
Summary: The Sterling OTW PTA Balloon Dilatation Catheter is a medical device used primarily in vascular procedures to dilate narrowed blood vessels. It is commonly used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K053116 ↗
Decision Date
December 16, 2005
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Sterling OTW PTA Balloon Dilatation Catheter by Boston Scientific was cleared through the FDA 510(k) pathway on December 16, 2005. It is classified as a Class 2 device under product code DQY.
What It Is
The Sterling OTW PTA Balloon Dilatation Catheter is a percutaneous transluminal angioplasty (PTA) device designed to open narrowed or blocked blood vessels. It works by inflating a balloon at the site of the stenosis, which compresses the plaque against the vessel wall, improving blood flow. This device is typically used over a guidewire, providing precise control during vascular interventions.
Clinical Applications
This catheter is commonly used in procedures to treat peripheral artery disease (PAD) and other vascular conditions. It is utilized in both hospital and outpatient settings by specialists such as interventional radiologists and vascular surgeons. The device is suitable for adult patients with arterial blockages, particularly in the lower extremities.
Indications for Use
The FDA indications for this device include the treatment of vascular stenosis in patients with peripheral artery disease. It is used to dilate narrowed blood vessels, improving circulation and alleviating symptoms associated with reduced blood flow.
Practical Considerations
The Sterling OTW PTA Balloon Catheter is available in various sizes to accommodate different vessel diameters and lesion lengths. It is compatible with standard guidewires and requires careful handling to ensure precise placement and inflation during procedures.
Frequently Asked Questions
What is the Sterling OTW PTA Balloon Catheter used for?
It is used to dilate narrowed blood vessels in patients with peripheral artery disease, improving blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for dilating stenotic vessels in patients with peripheral artery disease to improve circulation.
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.