📋 FDA Reference
Modification to Nanocross 0 14 OTW PTA Dilatation Catheter Models Ab14w020210090 Ab14w020210150
Summary: The Nanocross 0.14 OTW PTA Dilatation Catheter is a medical device used primarily in vascular procedures to dilate narrowed blood vessels. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K090849 ↗
Decision Date ?
May 1, 2009
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Nanocross 0.14 OTW PTA Dilatation Catheter by Ev3 was cleared through the FDA 510k pathway on May 1, 2009. It is classified as a Class 2 device under product code DQY.
What It Is
The Nanocross 0.14 OTW PTA Dilatation Catheter is a percutaneous transluminal angioplasty (PTA) catheter designed for use in vascular interventions. It is used to dilate stenotic segments of blood vessels, typically in the peripheral vasculature. The device operates over a guidewire and is designed to navigate through the vascular system to reach the target lesion.
FDA-Cleared Indications
- Dilating stenotic, or narrowed, segments of peripheral blood vessels during percutaneous transluminal angioplasty.
- Use with a compatible guidewire to access and treat a target vascular lesion.
- Intended for endovascular treatment of peripheral vascular disease when balloon dilation is clinically indicated.
Clinical Applications
- Balloon angioplasty of narrowed peripheral arteries.
- Treatment of flow-limiting stenoses associated with peripheral artery disease.
- Dilation of a selected vascular lesion after guidewire crossing and catheter positioning.
- Use in endovascular procedures performed by trained interventional specialists.
Practical Considerations
- The device is an over-the-wire catheter and requires a compatible guidewire, access sheath, imaging system and inflation equipment.
- The listed models have 0.14-inch guidewire compatibility; balloon diameter and working length must match the vessel size and lesion dimensions.
- The catheter should be advanced, positioned and inflated under appropriate fluoroscopic imaging, with attention to rated pressure and vessel injury risk.
- The FDA record provided does not establish MRI safety; MRI conditions should be confirmed in the current manufacturer labeling before scanning a patient.
- Potential contraindications and complications include inability to cross the lesion, severe vessel tortuosity, dissection, perforation, thrombosis, embolization, bleeding and contrast-related reactions.
Frequently Asked Questions
What is the Nanocross 0.14 OTW PTA Catheter used for?
It is used for dilating narrowed blood vessels, particularly in peripheral artery disease.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for dilating narrowed segments of peripheral arteries 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.