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optimus 0 035 inch pta balloon dilatation catheter
Usci Ireland
Summary: The Optimus 0.035 Inch PTA Balloon Dilatation Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) procedures. It is primarily used by interventional radiologists and cardiologists to treat vascular stenosis.
FDA Clearance Information
Pathway
510K
Number
K072156 ↗
Decision Date
November 9, 2007
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Optimus 0.035 Inch PTA Balloon Dilatation Catheter was cleared through the FDA 510(k) pathway on November 9, 2007. It is manufactured by Usci Ireland and classified as a Class 2 device under product code DQY.
What It Is
The Optimus 0.035 Inch PTA Balloon Dilatation Catheter is designed for use in percutaneous transluminal angioplasty procedures to dilate narrowed or obstructed blood vessels. The device consists of a balloon at the tip of a catheter that can be inflated to open up the vessel, improving blood flow. It is typically used in peripheral vascular interventions.
Clinical Applications
This catheter is commonly used in procedures to treat peripheral arterial disease, particularly in the lower extremities. Interventional radiologists and vascular surgeons use it in hospital or outpatient settings to restore blood flow in patients with vascular stenosis. It is suitable for adult patients who require endovascular treatment of narrowed blood vessels.
Indications for Use
The Optimus 0.035 Inch PTA Balloon Dilatation Catheter is indicated for use in patients with vascular stenosis, where it helps to widen narrowed blood vessels. It is particularly useful for treating peripheral arterial disease.
Practical Considerations
The catheter is compatible with standard 0.035-inch guidewires and is available in various balloon sizes to accommodate different vessel diameters. Proper technique involves careful navigation through the vasculature and precise balloon inflation to avoid vessel injury.
Frequently Asked Questions
What is the Optimus 0.035 Inch PTA Balloon Dilatation Catheter used for?
It is used for percutaneous transluminal angioplasty to dilate narrowed blood vessels and improve blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device in endovascular procedures.
What are the FDA-cleared indications?
It is indicated for use in patients with vascular stenosis to help widen narrowed blood vessels.
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.