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turbo-power 2 0mm laser atherectomy catheters
Spectranetics
Summary: The Turbo-Power 2.0mm Laser Atherectomy Catheters are used for removing atherosclerotic plaque from peripheral arteries. Interventional cardiologists and vascular surgeons typically use this device in endovascular procedures.
FDA Clearance Information
Pathway
510K
Number
K162561 ↗
Decision Date
January 5, 2017
Product Code
MCW
Device Class
Class 2
Evidence
0 studies
The Turbo-Power 2.0mm Laser Atherectomy Catheters were cleared via the FDA 510k pathway on January 5, 2017. Manufactured by Spectranetics, this device is classified as a Class 2 medical device under product code MCW.
What It Is
The Turbo-Power 2.0mm Laser Atherectomy Catheters are minimally invasive tools designed to remove plaque from peripheral arteries using laser technology. The device utilizes a laser to precisely ablate atherosclerotic material, improving blood flow. It is particularly useful in treating peripheral artery disease (PAD) and is designed for use in the femoral, popliteal, and other peripheral arteries.
Clinical Applications
This device is commonly used in endovascular procedures to treat patients with peripheral artery disease. It is often employed in settings such as catheterization labs and vascular surgery suites. Interventional cardiologists and vascular surgeons use it to restore blood flow in patients with significant arterial blockages, particularly in the lower extremities.
Indications for Use
The FDA indications for the Turbo-Power 2.0mm Laser Atherectomy Catheters include the removal of atherosclerotic plaque in peripheral arteries. It is intended for patients with peripheral artery disease who require revascularization to improve blood flow.
Practical Considerations
The device typically comes in a 2.0mm size, suitable for a range of peripheral arteries. It is compatible with standard guidewires and catheters used in endovascular procedures. Clinicians should be trained in laser atherectomy techniques to optimize outcomes and minimize complications.
Frequently Asked Questions
What is Turbo-Power 2.0mm Laser Atherectomy Catheters used for?
It is used to remove atherosclerotic plaque from peripheral arteries, improving blood flow in patients with peripheral artery disease.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device in endovascular procedures.
What are the FDA-cleared indications?
The device is indicated for the removal of atherosclerotic plaque in peripheral arteries to treat 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.