đź“‹ FDA Reference
modification to polarcath peripheral dilatation system
Boston Scientific
Summary: The Polarcath Peripheral Dilatation System is a medical device used for dilating peripheral blood vessels, primarily in venous stenting procedures. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K062594 ↗
Decision Date
September 20, 2006
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Polarcath Peripheral Dilatation System by Boston Scientific was cleared through the FDA's 510(k) pathway on September 20, 2006. It is a Class 2 device under product code DQY.
What It Is
The Polarcath Peripheral Dilatation System is designed to facilitate the dilation of peripheral blood vessels. It works by using a balloon catheter that is inserted into the vessel and then inflated to widen the vessel lumen. This device is particularly useful in procedures where vessel narrowing or blockages are present, allowing for improved blood flow.
Clinical Applications
This device is commonly used in procedures involving venous stenting, particularly in patients with peripheral artery disease or other conditions leading to vessel stenosis. It is typically utilized in hospital settings by specialists such as interventional radiologists and vascular surgeons. The device is suitable for adult patients who require vessel dilation to improve circulation.
Indications for Use
The FDA indications for the Polarcath Peripheral Dilatation System include its use in dilating peripheral blood vessels. It is intended for patients with conditions that cause narrowing or blockage of these vessels, such as peripheral artery disease.
Practical Considerations
Clinicians should consider the typical sizing of the balloon catheter to ensure compatibility with the patient's vessel size. Proper technique in catheter insertion and inflation is crucial to avoid complications. The device is compatible with standard guidewires and other interventional tools.
Frequently Asked Questions
What is the Polarcath Peripheral Dilatation System used for?
It is used for dilating peripheral blood vessels to improve blood flow, often in venous stenting procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for the dilation of peripheral blood vessels in patients with conditions like 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.