đź“‹ FDA Reference
nes reprocessed 0 9mm turbo elite laser atherectomy catheter
Northeast Scientific
Summary: The NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter is a device used to remove plaque from blood vessels. It is primarily used by interventional cardiologists and vascular surgeons to treat peripheral artery disease.
FDA Clearance Information
Pathway
510K
Number
K220171 ↗
Decision Date
July 1, 2022
Product Code
QTF
Device Class
Class 2
Evidence
0 studies
The NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter was cleared via the FDA 510k pathway on July 1, 2022. Manufactured by Northeast Scientific, it is a Class 2 device under product code QTF.
What It Is
This device is a laser atherectomy catheter designed to remove atherosclerotic plaque from blood vessels. It utilizes laser energy to vaporize plaque, thus restoring blood flow. The catheter is reprocessed, meaning it has been previously used and then sterilized for reuse, which can be a cost-effective option for healthcare facilities.
Clinical Applications
Commonly used in procedures to treat peripheral artery disease (PAD), this catheter is employed in settings such as catheterization labs. It is particularly useful in patients with significant plaque buildup in peripheral arteries, which can lead to symptoms like claudication. Interventional cardiologists and vascular surgeons are the primary users of this device.
Indications for Use
The device is indicated for patients with peripheral artery disease where plaque removal is necessary to improve blood flow. It is suitable for those with significant arterial blockages that are not amenable to balloon angioplasty alone.
Practical Considerations
The 0.9mm size of the catheter is suitable for small to medium-sized vessels. It is compatible with standard guidewires and sheaths used in peripheral interventions. Operators should be familiar with laser atherectomy techniques and consider vessel size and plaque characteristics when selecting this device.
Frequently Asked Questions
What is the NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter used for?
It is used to remove plaque from peripheral arteries to improve blood flow in patients with peripheral artery disease.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use this device in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for the removal of atherosclerotic plaque in patients with peripheral artery disease to restore 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.