đź“‹ FDA Reference
workhorse ii percutaneous transluminal angioplasty balloon catheter
Angiodynamics
Summary: The Workhorse II PTA Balloon Catheter is a medical device used for percutaneous transluminal angioplasty to open narrowed blood vessels. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K032069 ↗
Decision Date
August 27, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Workhorse II PTA Balloon Catheter was cleared through the FDA 510(k) pathway on August 27, 2003. Manufactured by Angiodynamics, it is classified as a Class 2 device under product code DQY.
What It Is
The Workhorse II PTA Balloon Catheter is designed for percutaneous transluminal angioplasty, a procedure to dilate narrowed or obstructed blood vessels. The device consists of a balloon at the tip of a catheter, which is inflated to widen the vessel. This helps improve blood flow and is commonly used in treating peripheral artery disease.
Clinical Applications
This catheter is primarily used in interventional radiology and vascular surgery settings. It is employed in procedures to treat patients with peripheral vascular disease, particularly those with stenotic or occluded arteries in the legs. The device is suitable for use in both hospital and outpatient settings, catering to adult patients with vascular conditions.
Indications for Use
The FDA-cleared indications for this device involve its use in dilating narrowed blood vessels, particularly in the peripheral vascular system. It is intended for patients with conditions like peripheral artery disease, where blood flow is compromised.
Practical Considerations
The Workhorse II PTA Balloon Catheter comes in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and requires careful handling to avoid vessel trauma. Clinicians should be trained in angioplasty techniques to ensure optimal outcomes.
Frequently Asked Questions
What is the Workhorse II PTA Balloon 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 commonly use this device.
What are the FDA-cleared indications?
The device is indicated for dilating narrowed blood vessels, particularly in the peripheral vascular system, to treat 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.