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Nanocorss 014 OTW PTA Dilatation Catheter
Product: NanoCross — all models and sizes · Where to buy · Find similar PTA balloons by size
Summary: The Nanocross 014 OTW PTA Dilatation Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) procedures. It is primarily utilized by interventional radiologists and vascular surgeons to treat vascular stenosis.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K082854 ↗
Decision Date ?
December 4, 2008
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Nanocross 014 OTW PTA Dilatation Catheter was cleared via the FDA 510(k) pathway on December 4, 2008. Manufactured by Ev3, it is a Class 2 device under product code DQY.
What It Is
The Nanocross 014 OTW PTA Dilatation Catheter is a specialized catheter designed for over-the-wire (OTW) use in percutaneous transluminal angioplasty (PTA). It is used to dilate narrowed sections of blood vessels, particularly in the peripheral vasculature. The device works by inflating a balloon at the site of stenosis to restore adequate blood flow.
FDA-Cleared Indications
- Use during percutaneous transluminal angioplasty to dilate stenotic peripheral blood vessels.
- Use in patients with peripheral vascular disease when balloon angioplasty is indicated to improve blood flow.
Clinical Applications
- Balloon angioplasty of narrowed peripheral arteries.
- Endovascular treatment of peripheral arterial stenosis in the lower extremities.
- Dilation of a peripheral vessel after guidewire access has been established.
- Treatment of peripheral vascular disease when restoring vessel diameter is clinically indicated.
Practical Considerations
- The catheter is an over-the-wire device and is designed for use with a compatible 0.014-inch guidewire.
- Balloon diameter and length must be selected to match the target vessel and lesion characteristics.
- Placement and inflation are performed under fluoroscopic or other appropriate imaging guidance by trained clinicians.
- The record provided does not establish MRI safety; consult the current device labeling before MRI.
- Contraindications, warnings, inflation limits, and compatibility requirements should be checked in the manufacturer’s instructions for use.
Frequently Asked Questions
What is the Nanocross 014 OTW PTA Dilatation Catheter used for?
It is used for percutaneous transluminal angioplasty (PTA) to dilate narrowed blood vessels, particularly in peripheral artery disease.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures to open narrowed blood vessels 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.