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intra-operative tec atherectomy system
Intensive Technology
Summary: The Intra-Operative TEC Atherectomy System is a medical device used to remove atherosclerotic plaque from blood vessels. It is typically used by vascular surgeons during procedures to restore blood flow in patients with peripheral artery disease.
FDA Clearance Information
Pathway
510K
Number
K922970 ↗
Decision Date
January 13, 1993
Product Code
MCW
Device Class
Class 2
Evidence
0 studies
The Intra-Operative TEC Atherectomy System was cleared through the FDA 510(k) pathway on January 13, 1993. Manufactured by Intensive Technology, it is classified as a Class 2 device under product code MCW.
What It Is
The Intra-Operative TEC Atherectomy System is a specialized surgical tool designed to excise atherosclerotic plaque from blood vessels. It operates by cutting and removing plaque, thereby improving blood flow. This device is particularly useful in treating peripheral artery disease, where plaque buildup can significantly impede circulation.
Clinical Applications
This device is commonly used in vascular surgery, especially in procedures aimed at treating peripheral artery disease. It is utilized in hospital operating rooms and specialized vascular centers. The primary patient population includes individuals with significant arterial blockages due to plaque buildup, often seen in older adults or those with risk factors like diabetes and smoking.
Indications for Use
The FDA-cleared indications for this device involve the removal of plaque from arteries to improve blood flow. It is intended for patients with peripheral artery disease, where plaque accumulation has led to significant narrowing of the vessels.
Practical Considerations
The device is typically available in various sizes to accommodate different vessel diameters. It is compatible with standard vascular surgical instruments and requires careful technique to avoid vessel damage. Clinicians should be trained in its use to ensure optimal outcomes.
Frequently Asked Questions
What is the Intra-Operative TEC Atherectomy System used for?
It is used to remove atherosclerotic plaque from blood vessels to improve blood flow, particularly in patients with peripheral artery disease.
What specialties typically use this device?
Vascular surgeons and interventional radiologists typically use this device during procedures to treat peripheral artery disease.
What are the FDA-cleared indications?
The device is indicated for the removal of plaque from arteries to improve blood flow 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.