đź“‹ FDA Reference
modification to nanocross 0 14 otw pta dilatation catheter models ab14w020210090 ab14w020210150
Ev3
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
510K
Number
K090849 ↗
Decision Date
May 1, 2009
Product Code
DQY
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.
Clinical Applications
This catheter is commonly used in procedures to treat peripheral artery disease (PAD), where it helps open narrowed arteries in the legs. It is used in both hospital and outpatient settings, primarily by interventional radiologists and vascular surgeons. The device is suitable for adult patients with vascular stenosis requiring intervention.
Indications for Use
The FDA indicates this device for use in dilating narrowed segments of blood vessels, particularly in the peripheral arteries. It is intended for patients with conditions like peripheral artery disease, where blood flow needs to be restored.
Practical Considerations
The catheter is typically available in various sizes to accommodate different vessel diameters and lesion lengths. It is compatible with standard guidewires and requires careful technique to ensure proper positioning and inflation within the vessel.
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.