đź“‹ FDA Reference
cordis aviator peripheral dilatation catheter
Cordis, A Johnson & Johnson
Summary: The Cordis Aviator Peripheral Dilatation Catheter is a medical device used for dilating peripheral vessels. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K013581 ↗
Decision Date
November 28, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Cordis Aviator Peripheral Dilatation Catheter was cleared through the FDA 510(k) pathway on November 28, 2001. It is manufactured by Cordis, a Johnson & Johnson company, and is classified as a Class 2 device.
What It Is
The Cordis Aviator Peripheral Dilatation Catheter is a balloon catheter designed for dilating peripheral blood vessels. It works by inflating a balloon at the site of a stenosis or blockage, thereby expanding the vessel and improving blood flow. The device is engineered for precision and control, making it suitable for complex vascular procedures.
Clinical Applications
This catheter is commonly used in procedures to treat peripheral artery disease (PAD) and other vascular conditions. It is typically utilized in interventional radiology and vascular surgery settings, where clinicians perform angioplasty to open narrowed or blocked blood vessels in the legs, arms, or other peripheral areas. Patients with PAD or those requiring venous stenting are typical candidates.
Indications for Use
The device is indicated for use in patients with peripheral vascular disease, where it helps to dilate narrowed or obstructed blood vessels. It is particularly useful in treating conditions that cause reduced blood flow to the limbs.
Practical Considerations
The catheter is available in various sizes to accommodate different vessel diameters and lesion lengths. It is compatible with standard guidewires and introducer sheaths. Clinicians should consider vessel size and lesion characteristics when selecting the appropriate catheter size.
Frequently Asked Questions
What is the Cordis Aviator Peripheral Dilatation Catheter used for?
It is used to dilate narrowed or blocked peripheral blood vessels, improving blood flow.
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 dilating peripheral vessels in patients with peripheral vascular 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.