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optimus 0 035 pta balloon dilatation catheter
Usci Ireland
Summary: The Optimus 0 035 PTA Balloon Dilatation Catheter is a medical device used to dilate blood vessels in peripheral vascular procedures. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K082646 ↗
Decision Date
November 3, 2008
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Optimus 0 035 PTA Balloon Dilatation Catheter was cleared through the FDA 510(k) pathway on November 3, 2008. Manufactured by Usci Ireland, it is classified as a Class 2 device under product code DQY.
What It Is
The Optimus 0 035 PTA Balloon Dilatation Catheter is designed to facilitate the dilation of stenotic segments in blood vessels. It works by inflating a balloon at the site of a vascular narrowing, thereby widening the vessel to improve blood flow. This device is particularly useful in peripheral artery disease interventions.
Clinical Applications
This catheter is commonly used in procedures to treat peripheral artery disease, where it helps restore adequate blood flow in narrowed or blocked arteries. It is frequently utilized in interventional radiology and vascular surgery settings, and is suitable for adult patients with vascular stenosis. The device is often employed in outpatient or hospital-based catheterization labs.
Indications for Use
The FDA-cleared indications for this device include the treatment of vascular stenosis, particularly in peripheral arteries. It is intended for patients who require vessel dilation to improve blood circulation.
Practical Considerations
The catheter is available in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and requires careful handling to avoid vessel injury during insertion and inflation. Clinicians should be familiar with balloon sizing and inflation techniques to optimize outcomes.
Frequently Asked Questions
What is the Optimus 0 035 PTA Balloon Dilatation Catheter used for?
It is used to dilate narrowed blood vessels in peripheral vascular procedures, improving 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 the dilation of stenotic segments in peripheral arteries 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.