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vaccess pta dilatation catheter
C.R. Bard
Summary: The Vaccess PTA Dilatation Catheter is a medical device used for percutaneous transluminal angioplasty (PTA) to dilate narrowed blood vessels. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K111850 ↗
Decision Date
July 13, 2011
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Vaccess PTA Dilatation Catheter was cleared through the FDA 510(k) pathway on July 13, 2011. Manufactured by C.R. Bard, it is classified as a Class 2 device under product code DQY.
What It Is
The Vaccess PTA Dilatation Catheter is designed for percutaneous transluminal angioplasty, a procedure to open up narrowed or blocked blood vessels, typically in the peripheral vascular system. This catheter is inserted into the vessel and inflated at the site of the stenosis to widen the vessel and improve blood flow. It is a critical tool in managing peripheral artery disease and other vascular conditions.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery settings. It is employed in procedures to treat peripheral artery disease, particularly in the legs, and can be used in both inpatient and outpatient settings. The device is suitable for adult patients with vascular stenosis requiring intervention to restore adequate blood flow.
Indications for Use
The Vaccess PTA Dilatation Catheter is indicated for use in patients with narrowed blood vessels that need to be widened to improve blood flow. It is particularly useful in treating peripheral artery disease and other conditions that cause vascular stenosis.
Practical Considerations
The catheter comes in various sizes to accommodate different vessel diameters and lesion lengths. It is compatible with standard guidewires and introducer sheaths. Clinicians should be familiar with angioplasty techniques and the specific handling of balloon catheters to ensure optimal outcomes.
Frequently Asked Questions
What is the Vaccess PTA Dilatation Catheter used for?
It is used for percutaneous transluminal angioplasty to dilate narrowed blood vessels and improve blood flow.
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 blood vessels to improve blood flow, particularly in peripheral artery 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.