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dorado pta balloon dilatation catheter
Bard Peripheral Vascular
Summary: The Dorado PTA Balloon Dilatation Catheter is a medical device used to treat stenosis in blood vessels. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K072283 ↗
Decision Date
September 19, 2007
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 September 19, 2007. It is manufactured by Bard Peripheral Vascular and classified as a Class 2 device.
What It Is
The Dorado PTA Balloon Dilatation Catheter is designed for percutaneous transluminal angioplasty (PTA) procedures. It works by inflating a balloon within a blood vessel to dilate stenotic segments, improving blood flow. This device is particularly useful in treating peripheral arterial disease and is engineered for flexibility and precision in challenging vascular anatomy.
Clinical Applications
This catheter is commonly used in procedures to treat peripheral artery disease, especially in the lower extremities. It is often employed in hospital settings, outpatient vascular centers, and dialysis clinics. The device is suitable for patients with vascular stenosis, including those with dialysis fistulas requiring intervention to maintain patency.
Indications for Use
The FDA indications for the Dorado PTA Balloon Dilatation Catheter include use in dilating stenotic segments of blood vessels. It is particularly indicated for patients with peripheral vascular disease and can be used in both arterial and venous applications.
Practical Considerations
The Dorado PTA Balloon Dilatation Catheter comes in various sizes to accommodate different vessel diameters and lesion lengths. It is compatible with standard guidewires and sheaths, and clinicians should be familiar with balloon inflation techniques to optimize outcomes.
Related Literature
The linked study investigated the use of drug-eluting balloon angioplasty for recurrent cephalic arch stenosis in dialysis fistulas. While the abstract is not available, such studies typically focus on the efficacy of drug-eluting technology in reducing restenosis rates. Limitations may include sample size and lack of long-term follow-up data.
Frequently Asked Questions
What is the Dorado PTA Balloon Dilatation Catheter used for?
It is used to dilate stenotic segments of blood vessels, improving blood flow in patients with peripheral vascular disease.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for dilating stenotic segments of blood vessels, particularly 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.