đź“‹ FDA Reference
turbo-power 2 0mm laser atherectomy catheters turbo-power 2 3mm laser atherectomy catheters
Spectranetics
Summary: The Turbo-Power 2.0mm and 3.0mm laser atherectomy catheters are used for the removal of atherosclerotic plaque in peripheral arteries. They are typically used by interventional cardiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K222837 ↗
Decision Date
December 8, 2022
Product Code
MCW
Device Class
Class 2
Evidence
0 studies
The Turbo-Power laser atherectomy catheters were cleared through the FDA 510(k) pathway on December 8, 2022. Manufactured by Spectranetics, these devices are classified as Class 2 under product code MCW.
What It Is
The Turbo-Power laser atherectomy catheters are minimally invasive devices designed to remove atherosclerotic plaque from peripheral arteries. Utilizing laser technology, these catheters ablate plaque by delivering controlled laser energy. This helps to restore blood flow and improve vessel patency. The devices are available in 2.0mm and 3.0mm sizes to accommodate different vessel diameters.
Clinical Applications
These catheters are commonly used in procedures to treat peripheral artery disease (PAD), particularly in the lower extremities. They are employed in settings such as catheterization labs and vascular surgery suites. The devices are suitable for patients with significant arterial blockages that are not amenable to balloon angioplasty alone.
Indications for Use
The FDA-cleared indications for these devices include the treatment of atherosclerotic lesions in peripheral arteries. They are intended for patients who require plaque removal to restore adequate blood flow.
Practical Considerations
The Turbo-Power catheters come in 2.0mm and 3.0mm sizes, allowing for flexibility in treating various vessel sizes. They are compatible with standard guidewires and require a laser console for operation. Clinicians should be trained in laser atherectomy techniques to ensure optimal outcomes.
Frequently Asked Questions
What is the Turbo-Power laser atherectomy catheter used for?
It is used for the removal of atherosclerotic plaque in peripheral arteries to restore blood flow.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for the treatment of atherosclerotic lesions in peripheral arteries to restore adequate blood flow.
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.