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evercross 035 otw pta dilatation catheter
Ev3
Summary: The EverCross 035 OTW PTA Dilatation Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) procedures. It is primarily used by interventional radiologists and vascular surgeons to treat vascular stenosis.
FDA Clearance Information
Pathway
510K
Number
K082579 ↗
Decision Date
November 20, 2008
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The EverCross 035 OTW PTA Dilatation Catheter was cleared through the FDA 510(k) pathway on November 20, 2008. Manufactured by Ev3, it is classified as a Class 2 device under product code DQY.
What It Is
The EverCross 035 OTW PTA Dilatation Catheter is designed for use in percutaneous transluminal angioplasty (PTA) to dilate stenosed blood vessels. It features an over-the-wire (OTW) design, allowing for precise navigation and placement within the vascular system. The catheter is equipped with a balloon that can be inflated to open narrowed or blocked vessels, improving blood flow.
Clinical Applications
This catheter is commonly used in procedures to treat peripheral artery disease (PAD) and other vascular conditions involving stenosis. It is utilized in both hospital and outpatient settings by interventional radiologists and vascular surgeons. The device is suitable for a wide range of patients, including those with atherosclerotic disease affecting the peripheral arteries.
Indications for Use
The EverCross 035 OTW PTA Dilatation Catheter is indicated for use in dilating stenosed arteries to improve blood flow. It is particularly useful for patients with peripheral artery disease who require intervention to restore adequate circulation.
Practical Considerations
The catheter is available in various sizes to accommodate different vessel diameters and lesion lengths. It is compatible with standard guidewires and requires careful technique to ensure proper placement and inflation. Clinicians should be familiar with angioplasty procedures to optimize outcomes.
Frequently Asked Questions
What is the EverCross 035 OTW PTA Dilatation Catheter used for?
It is used for percutaneous transluminal angioplasty to dilate stenosed blood vessels and improve 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 dilating stenosed arteries to improve blood flow, particularly in patients with peripheral artery disease.
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.