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viatrac 14 plus peripheral dilatation catheter
Guidant
Summary: The Viatrac 14 Plus Peripheral Dilatation Catheter is a medical device used for dilating peripheral blood vessels. It is typically used by interventional radiologists and vascular surgeons in procedures involving venous stents.
FDA Clearance Information
Pathway
510K
Number
K012050 ↗
Decision Date
September 6, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Viatrac 14 Plus was cleared through the FDA 510k pathway on September 6, 2001. Manufactured by Guidant, it is classified as a Class 2 device under product code DQY.
What It Is
The Viatrac 14 Plus Peripheral Dilatation Catheter is a balloon catheter designed to dilate peripheral blood vessels. It works by inflating a balloon at the site of a vascular stenosis to widen the vessel and improve blood flow. This device is essential in procedures where precise vessel dilation is required, particularly in the placement of venous stents.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures involving the treatment of peripheral artery disease and in the placement of venous stents. Patients with narrowed or blocked peripheral blood vessels, such as those with atherosclerosis, are typical candidates for procedures using this device.
Indications for Use
The FDA-cleared indications for this device include the dilation of peripheral blood vessels to facilitate the placement of venous stents. It is used in patients with conditions that cause narrowing or blockage of these vessels.
Practical Considerations
The Viatrac 14 Plus is available in various balloon sizes to accommodate different vessel diameters. It is compatible with standard guidewires and requires careful handling to ensure precise placement and inflation. Clinicians should be familiar with the specific technique for balloon inflation and deflation to optimize outcomes.
Frequently Asked Questions
What is the Viatrac 14 Plus Peripheral Dilatation Catheter used for?
It is used for dilating peripheral blood vessels, particularly in procedures involving venous stents.
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 the dilation of peripheral blood vessels to assist in the placement of venous stents.
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.