đź“‹ FDA Reference
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 ?
510(k)
Number ?
K922970 ↗
Decision Date ?
January 13, 1993
Product Code ?
MCW Catheter, Peripheral, Atherectomy
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.
FDA-Cleared Indications
- Removal of atherosclerotic plaque from peripheral blood vessels.
- Use in patients with peripheral arterial obstruction or narrowing caused by atherosclerosis.
- Intended to improve blood flow by excising obstructive plaque.
Clinical Applications
- Atherectomy during surgical treatment of atherosclerotic peripheral arterial disease.
- Removal of plaque from narrowed peripheral arteries to improve circulation.
- Use during vascular procedures in which direct excision of arterial plaque is indicated.
- Treatment of peripheral arterial blockages in appropriately selected patients.
Practical Considerations
- The device is a Class II peripheral atherectomy catheter under FDA product code MCW.
- The available device size should match the treated vessel and the procedural approach.
- Use requires trained vascular clinicians and careful handling to reduce the risk of vessel injury, dissection, perforation or embolization.
- The FDA record provided does not establish MRI safety; MRI compatibility should be confirmed from the device labeling or manufacturer before scanning.
- Medication, balloon angioplasty, stenting or bypass surgery may be alternatives or may be used in combination, depending on the anatomy and clinical situation.
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.