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 ?
510(k)
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.
FDA-Cleared Indications
- Use in peripheral arterial vessels during laser atherectomy procedures to remove or reduce atherosclerotic plaque.
- Use as part of endovascular treatment for peripheral artery disease when plaque limits blood flow.
- Use by trained clinicians familiar with laser atherectomy and peripheral vascular interventions.
Clinical Applications
- Laser atherectomy for plaque in peripheral arteries.
- Treatment of peripheral arterial lesions that may require plaque modification before or with balloon angioplasty.
- Endovascular treatment of peripheral artery disease in a catheterization or vascular intervention laboratory.
- Plaque removal intended to improve blood flow in an affected limb.
Practical Considerations
- The catheter has a 0.9 mm profile; vessel size, lesion characteristics and access anatomy must be assessed before use.
- Use requires compatible guidewires, introducer sheaths and laser atherectomy equipment specified in the device instructions for use.
- Laser atherectomy should be performed by clinicians trained in the technique, with imaging guidance and appropriate management of embolic, perforation and thrombotic risks.
- Because this is a reprocessed device, the facility should follow the manufacturer's instructions for inspection, preparation, sterilization status and single-use or reuse limitations.
- MRI safety and conditional-use information should be confirmed in the current labeling; do not assume the catheter is safe for MRI while it is implanted or retained.
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.