đź“‹ FDA Reference
dorado pta balloon dilatation catheter
Bard Peripheral Vascular
Summary: The Dorado PTA Balloon Dilatation Catheter is a medical device used for percutaneous transluminal angioplasty. It is primarily utilized by interventional radiologists and vascular surgeons to treat stenotic lesions in venous systems.
FDA Clearance Information
Pathway
510K
Number
K250219 ↗
Decision Date
June 17, 2025
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Dorado PTA Balloon Dilatation Catheter was cleared through the FDA 510(k) pathway on June 17, 2025. Manufactured by Bard Peripheral Vascular, it is classified as a Class 2 device under product code DQY.
What It Is
The Dorado PTA Balloon Dilatation Catheter is designed for percutaneous transluminal angioplasty (PTA), a procedure to open narrowed or blocked blood vessels. It consists of a balloon that is inflated at the site of a stenosis to widen the vessel, improving blood flow. This device is particularly useful in treating peripheral vascular diseases, including those affecting the venous system.
Clinical Applications
Commonly used in interventional radiology and vascular surgery, the Dorado PTA Balloon Dilatation Catheter is employed in procedures to treat venous stenosis, particularly in patients with dialysis fistulas or grafts. It is used in hospital settings and outpatient centers, often in patients with chronic kidney disease requiring dialysis access maintenance.
Indications for Use
The device is indicated for use in patients with stenotic lesions in the venous system, often related to dialysis access. It helps restore adequate blood flow in narrowed vessels, which is crucial for effective dialysis treatment.
Practical Considerations
The Dorado PTA Balloon Dilatation Catheter comes in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and requires fluoroscopic guidance for accurate placement. Clinicians should be familiar with angioplasty techniques to optimize outcomes.
Related Literature
The linked study investigated the use of drug-eluting balloon angioplasty for treating recurrent cephalic arch stenosis in dialysis fistulas. Although specific details are unavailable, such studies typically focus on the efficacy of drug-eluting technologies in reducing restenosis rates. Limitations may include small sample sizes or lack of long-term follow-up data.
Frequently Asked Questions
What is Dorado PTA Balloon Dilatation Catheter used for?
It is used for percutaneous transluminal angioplasty to treat stenotic lesions in the venous system, particularly in dialysis patients.
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 treating stenotic lesions in the venous system, often related to dialysis access.
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.